Catalyst Clinical Research

As a Senior Clinical Research Associate you will be a key member of the Development Operations, Clinical Monitoring Team. The Senior Clinical Research Associate monitors clinical trial programs and manages regional clinical trial sites to support biological and pharmaceutical developmental programs in a manner consistent with relevant global regulations along with Catalyst Clinical Research LLC’s applicable SOPs and working practices. You will be involved in all stages of clinical trials, including the identification of an investigational site and evaluating, initiating, monitoring and closing out a trial. The Sr. CRA will work closely with the project team in order to ensure compliance with appropriate regulations and guidelines throughout the trial and will conduct data analysis to ensure this meets the required clinical standards. The Sr. CRA will ensure the rights and safety of human subjects involved in a clinical study are protected at all times. The Sr. CRA may assume Clinical Trial Lead responsibilities. Position Responsibilities/Accountabilities: • Monitor clinical trials according to monitoring plans to achieve project goals; conduct or assist with site evaluations, study initiations, routine monitoring and site close- outs, and complete visit related documentation within specified company timeline. • Work with the study start up team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents. • Assist site staff in driving patient recruitment and develop enrollment plans in conjunction with site staff. • Perform data review activities, collaborate with data management to identify trends and implement corrective action to enhance data quality. • Ensure study documentation is maintained in the Investigator Study File and where necessary ensure relevant documents are transferred or copied to the (electronic) Trial Master File. • Document accountability, stability and storage conditions of clinical trial materials as required by the sponsor. • Perform investigational product inventory and ensure return of unused materials to designated location/verify destruction as required. • Effectively communicate with site study staff and Catalyst Clinical Research LLC. clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study related issues. • Pro-actively manage site issues and incorporate a root cause analysis and corrective action and preventive action plan. • Coordinate with the ethics committee in order to ensure the rights, safety and well-being of all trial subjects including provision of updates according to local requirements. • Participate in project audit/inspection preparation and conduct, as necessary, and assist with audit/inspection responses. • Collaborate closely with the Project Manager and Clinical Trial Lead. • Work closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor, and other trial staff. • Maintain a home office if working remotely. Manage work activities in a time- and cost- effective manner to ensure budgetary guidelines and project timelines are met. • Participate in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines. • May provide training including but not limited to co-monitoring for new monitors regardless of their previous monitoring experience. • May act as the point of contact for a client for CRA responsibilities and study related tasks. • May develop monitoring tools and forms. • May assist in leading CRA meetings and documenting meeting minutes. • May assist in the preparation of study documents such as annotated visit reports and visit report templates, Clinical Monitoring Plan, cohort management plan, study specific templates, SIV training presentation, study operations manual, source data verification plan, laboratory manual and informed consents. Managerial Requirements/ Responsibilities: N/A Position Qualifications/Requirements: Education: University/college degree in life sciences preferred (or the equivalent of 5-6 years industry experience, or certification in a related allied health profession from an appropriately accredited institution, such as nursing, medical or laboratory technology, or equivalent, relevant experience. Experience: Minimum of 5 years CRA direct monitoring experience with a sponsor company or CRO, or other related experience. At least 2 years experience monitoring trials in oncology /heamatology Required Certifications: N/A Required Skills: • Strong knowledge of Australian clinical trial regulations, as appropriate, and ICH GCP guidelines. • Good knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. • Good knowledge of assigned therapeutic area. • Proficient with Microsoft Office Suite. • Excellent written and oral communication skills. • Excellent presentation skills. • Strong organizational, problem-solving, and analytical skills. • Ability to manage priorities and workflow. • Versatility, flexibility, and a willingness to work within constantly changing priorities. • Proven ability to handle multiple projects and meet deadlines. • Strong interpersonal skills. • Ability to deal effectively with a diversity of individuals at all organizational levels. • Commitment to excellence and high standards. • Creative, flexible, and innovative team player. • Ability to work independently and as a member of various teams and committees. • Good judgement with the ability to make timely and sound decisions. • Ability and willingness to travel up to 70%, as needed.

As a Clinical Trial Manager you will be responsible for leading the delivery of clinical study site management activities through the co-ordination of a team of Clinical staff within a geographic region. You will be responsible for ensuring site qualification, initiation, interim monitoring, site management and study close-out activities for studies in accordance with the with study protocol and study plan and Worldwide Standard Operating Procedures (SOPs). Ensures overall quality and timeliness of Clinical deliverables for assigned programs and/or region. Alternatively, may act as Report Reviewer.* Position Accountabilities/Responsibilities: _Tasks may include but are not limited to:_ Collaborate with Project Management to set site management targets/monitoring strategy and ensure compliance with project goals and Worldwide processes Provide leadership and direction to clinical site management team members from study start through to closure Serve as Site Management (SM) primary point of contact and representative for clinical monitoring and site activities within the project, including, but not limited to: Primary SM Sponsor contact Investigator and Bid Defense Meeting Internal and External study team calls Project specific Audits / Inspections Manage monitoring deliverables to achieve study budget and identify Out of Scope Activities Customize study-specific SM Quality Management Documents, e.g. the Clinical Monitoring Plans (CMP) Oversee compliance to the CMP, including site visits, outstanding trip reports and visit follow up letters Review protocol deviations and visit action items to ensure that activities are conducted according to the CMP. Provide CRAs training all clinical aspects of the study with support from Project Management, Medical Monitoring and Sponsor as needed Participate in the development and implementation of patient recruitment strategy in countries and sites assigned. Lead the tracking of recruitment and revision of site-specific recruitment plans as needed to ensure enrollment stays on target Drive efforts to improve the quality of site data and address any identified needs with action plans. Review data metrics to ensure data integrity and quality Track/measure SM deliverables to identify trends. Provide and monitor regular analytics through various project tracking systems such as project financial performance reports, study metrics and trending; resource allocation to project tasks, time recognition and other systems as needed Oversee TMF (Trial Management File) compliance of site management documents, ensuring that QC review is on target and TMF is inspection ready Formulate regional monitoring strategy and accountable for forecasting of site visits with CRA team in line with CMP to ensure staffing needs are met and any identified backlog is appropriately addressed Review/finalize trip reports according to Worldwide SOPs and expectations May perform site qualification, initiation, interim monitoring, and/or close out site visits as needed Provide a key role in problem solving and first line issue escalation regarding monitoring and site issues, providing proposed solutions to the project management team and sponsor as needed Proactively identify and mitigate risks May represent site management as primary contact on projects Conduct co-visits where required to ensure quality of site, the CRA work and study procedures. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Other Skills and Abilities: Excellent interpersonal, oral and written communication skills in English Excellent planning and organizational skills with effective time management Excellent presentation skills Flexibility to change Ability to manage multiple and varied tasks with enthusiasm Ability to negotiate and influence with diplomacy in order to achieve results Demonstrate initiative and problem-solving skills by offering solutions when obstacles are identified Must be able to prioritize tasks with attention to detail, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision Ability to lead and motivate a team remotely Ability to provide experience and input into process initiatives and development relating to monitoring and site management activities Strong customer focus, ability to interact professionally within a sponsor contact Extensive understanding of clinical research principles and process Strong understanding of FDA and /or EU Directive regulations, ICH Guidelines and local regulatory requirements Experience in the study therapeutic indication/area Thorough understanding of standard operating procedures Proficient knowledge of Microsoft Office, eCRF, IVRS packages Proficiency with IxRS, CTMS and EDC systems Requirements/Qualifications: Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies and a minimum experience of three years as a Senior Clinical Research Associate (or equivalent), OR Two-year college curriculum or equivalent education/training (nursing degree or equivalent life science degree preferred) and a minimum experience of five years as a Senior Clinical Research Associate, OR Minimum 6-month experience functioning as CTM/LCRA (or equivalent); supporting main CTM and coordinating clinical operations activities Travel required Valid current passport required Driving license required Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. *Note the Clinical Trial Manager role may also be referred to as a Lead Clinical Research Associate (LCRA)* Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.

As a Senior Clinical Data Manager you will oversee, lead, manage and provide technical expertise within the assigned projects to ensure that they are executed in an efficient, accurate and timely manner to the Sponsor’s satisfaction. Position Accountabilities/Responsibilities: - Provide fully independent and autonomous leadership of data management services (start up, conduct and close out)​ across multiple complex global projects/programs, including: - Ensure appropriate resources are allocated to complete all DM activities on time and budget. - Prepare DM trial documentation (DMP, DB Specifications, Edit check specifications, CCGs, DTAs). - Ensure effective UAT is performed. - Write external vendor reconciliation specifications for programming reconciliation outputs (e.g. Serious Adverse Events, IRT, Central Laboratory).​ - Oversee data cleaning activities. - Produce metrics to monitor progress of trial activities. - Ensure all database lock activities are completed on time. - Represent WorldWide DM at both internal and external study meeting calls, including providing input.​ - Monitor project scope, budgets and risks and alert DM Management of any concerns. - Liaise with DM Management at regular intervals to discuss progress and any issues outstanding (e.g. during Project Review Meetings).​ - Collaborate with internal Worldwide departments working on the same project​. - Provide feedback on process improvements to DM Management and/or SMEs. - Participate in and lead process reviews. - Provide training, support and mentorship to other members of the DM department. - Participate as necessary in sponsor audits, regulatory authority inspections and other third party meetings. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. Other skills and abilities: - Excellent attention to detail. - Excellent written and verbal communication skills. - Strong knowledge of data management best practices & technologies as applied to clinical trials. - Excellent communication and interpersonal skills to collaborate with cross-functional internal and external teams. - Strong understanding of clinical trial process and protocols documents (protocols, statistical analysis plans, CRFs, study reports) and processes. - Strong analytical and problem solving skills. - Independent and autonomous project oversight skills. Requirements/Qualifications: - Bachelor’s degree or higher in biomedical sciences, life sciences, computer science or related discipline — or equivalent relevant experience. - Min of 5 years of experience in clinical data management or a related role within the pharmaceutical, biotechnology, or medical device industries. Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.

As a Project Manager you are a key member of the Development Operations, Project Management Team. You are accountable for achieving successful delivery of clinical trial team activities at the trial/program level by meeting contractually agreed sponsor and regulatory requirements according to Scope of Work (SOW) and agreed upon timelines. You will lead and direct cross functional teams and understand/manage sponsor expectations. You will proactively identify, resolve/mitigate, and escalate risks and/or issues. Position Responsibilities/Accountabilities: - Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs (can be more than one) from protocol inception through Clinical Study Report and trial close out. - Responsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs. - Responsible for communication to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines. - Responsible for timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues. - In collaboration with the trial/program team and all stakeholders ensures the completion of all project deliverables from contract signature to delivery of final clinical study report and project close out complying with ICH GCP requirements. - Responsible to manage study vendors, patient enrollment and liaise with investigators and study sites. - Lead cross-functional teams while understanding and managing client expectations. - Responsible for working with the sponsor, subcontractors and Catalyst assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations. - Responsible to proactively identify, resolve/mitigate, and escalate risks or issues when necessary and proactively communicate to the project team any issue that may negatively impact the overall project, seeking a collaborative resolution. - Continually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved. - Perform project status tracking and reporting including participation in the monthly project review with the ELT. - Accountable for the overall integration and communication of the study parameters to all stakeholders/partners (sub-contractors, strategic partners, internal partners, and Sponsor representatives) to ensure the execution of the work product. - Ensure effective project plans (i.e., Clinical Monitoring Plan, Communication Plan, Project Management Plan, Vendor Oversight Plan, Recruitment Plan) are developed and in place and optimal for the trial as per SOW and company Standard Operating Procedures (SOPs). - Work proactively with the clinical trial team to set priorities in accordance with applicable project plan, company SOP and procedures, International Conference on Harmonization-Good Clinical Practice (ICH/GCP) guidelines and regulatory requirements. - Responsible for oversight of the Clinical Monitoring Plan to ensure a consistent approach to monitoring is maintained throughout the study. - Per SOW collaborate with internal safety team member or Safety Vendor to develop Safety Management Plan and ensure the internal and extended team members are trained on the plan. - Proactively report project resource needs to management (overage as well as shortage). - Contribute to the development of site initiation presentations and in collaboration with the Clinical Research Associate (CRA) and sponsor deliver to sites for initiation purposes. - Provide project/trial level input and coordination of tasks supporting the following deliverables: feasibility analysis, recruitment projections, data collection status, data cleaning progress and strategy, data lock tracking and overall reporting of deliverable timelines. - Develops and revises trial and site recruitment strategies/plan to support achieving the recruitment goal as driven by project milestones. - Collaborate with Central Site Services in the development of the templates for the investigator contract and budget, and investigator Grant payments process. - Team with cross functional team members (i.e., Data Management (DM), Clinical Science (CS) and Biostats) in protocol deconstruction eCRF (Electronic Case Report Form) development, the development and review of the data management plan, edit specifications, eCRF completion guidelines, diaries, questionnaires, and data screens. - Throughout the course of the project, monitor and QC the electronic Trial Master File (eTMF) to ensure that the required trial documentation is filed per the TMF reference model. - At study close out responsible for oversight and transfer of a quality eTMF to the sponsor. - Collaborate with internal team, sponsor, medical monitor, and partners to develop agenda and content of the project team meetings. - Lead the project, site, internal and vendor meetings and ensure meeting minutes and action items are captured, distributed to all team members, sponsor, and management. - In collaboration with CS and DM review and identify study data for trends (per company process) and in collaboration with the internal team develop a plan (retraining of sites etc.) to address any issues or concerns with the data collection/data entry. - Participate as needed in data review meetings in collaboration with DM, CS and Biostats, internally and with the sponsor to review data for trends or issues and develop an action plan to address any questions or concerns. - Monitor the quality of vendor deliverables, address any issues with the appropriate team members and identify opportunities to improve training, execution, and quality across the team. Responsible for oversight of any changes to the study because of a protocol amendment as per the SOW. This includes ensuring study related documents (i.e., Amendment, ICFs, manuals, plans, eCRF, eCRF completion guidelines and contracts) are updated and distributed/communicated to the internal and external team and vendors in a timely manner. - Responsible for oversight of Corrective and Preventative Action Plan (CAPA) process implementation as needed for assigned trials. Collaborates with cross functional teams, Clinical Operations Management and Quality Management on CAPA plan, process, and implementation. - Responsible to review and provide input to corrective and preventative actions for Internal Quality Review (IQR) findings for assigned studies and works with Clinical Operations Management to address findings. - Facilitate and assist Medical Writing in the development of the Clinical Study Reports (CSRs). - Maintain proficiency to current ICH and GCP regulations, guidelines, and white papers as they apply to areas of study. Position Qualification Requirements: Education: Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required. Experience: Minimum of 5 years’ experience with clinical research methodology and product development activities (IND filing, study design, monitoring, study coordination, data management, data analysis, NDA submissions) and prior project management or project lead coordination experience. Required Certifications: N/A Required Skills: - Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners. - Exceptional attention to detail and timelines. - Demonstrated track record in leading successful teams to achieve aggressive timelines using creative problem-solving techniques. - Collaborative leadership style. - Preferred experience in bid defense process - Ability and willingness to travel as needed. - Proficient with Microsoft Office Suite. - Excellent written and oral communication skills. - Strong organizational, problem-solving, and analytical skills. - Versatility, flexibility, and a willingness to work within constantly changing priorities. - Proven ability to handle multiple projects and meet deadlines. - Ability to deal effectively with a diversity of individuals at all organizational levels. - Commitment to excellence and high standards. - Ability to work independently and as a member of various teams and committees. - Good judgement with the ability to make timely and sound decisions.

As a Senior Project Manager you are a key member of the Development Operations, Project Management Team. You are accountable for achieving successful delivery of clinical trial team activities at the trial/program level by meeting contractually agreed sponsor and regulatory requirements according to Scope of Work (SOW) and agreed upon timelines. You will lead and direct cross functional teams and understand/manage sponsor expectations. You will proactively identify, resolve/mitigate, and escalate risks and/or issues. Position Responsibilities/Accountabilities: - Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs (can be more than one) from protocol inception through Clinical Study Report and trial close out. - Responsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs. - Responsible for communication to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines. - Responsible for timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues. - In collaboration with the trial/program team and all stakeholders ensures the completion of all project deliverables from contract signature to delivery of final clinical study report and project close out complying with ICH GCP requirements. - Responsible to manage study vendors, patient enrollment and liaise with investigators and study sites. - Lead cross-functional teams while understanding and managing client expectations. - Responsible for working with the sponsor, subcontractors and Catalyst assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations. - Responsible to proactively identify, resolve/mitigate, and escalate risks or issues when necessary and proactively communicate to the project team any issue that may negatively impact the overall project, seeking a collaborative resolution. - Continually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved. - Perform project status tracking and reporting including participation in the monthly project review with the ELT. - Accountable for the overall integration and communication of the study parameters to all stakeholders/partners (sub-contractors, strategic partners, internal partners, and Sponsor representatives) to ensure the execution of the work product. - Ensure effective project plans (i.e., Clinical Monitoring Plan, Communication Plan, Project Management Plan, Vendor Oversight Plan, Recruitment Plan) are developed and in place and optimal for the trial as per SOW and company Standard Operating Procedures (SOPs). - Work proactively with the clinical trial team to set priorities in accordance with applicable project plan, company SOP and procedures, International Conference on Harmonization-Good Clinical Practice (ICH/GCP) guidelines and regulatory requirements. - Responsible for oversight of the Clinical Monitoring Plan to ensure a consistent approach to monitoring is maintained throughout the study. - Per SOW collaborate with internal safety team member or Safety Vendor to develop Safety Management Plan and ensure the internal and extended team members are trained on the plan. - Proactively report project resource needs to management (overage as well as shortage). - Contribute to the development of site initiation presentations and in collaboration with the Clinical Research Associate (CRA) and sponsor deliver to sites for initiation purposes. - Provide project/trial level input and coordination of tasks supporting the following deliverables: feasibility analysis, recruitment projections, data collection status, data cleaning progress and strategy, data lock tracking and overall reporting of deliverable timelines. - Develops and revises trial and site recruitment strategies/plan to support achieving the recruitment goal as driven by project milestones. - Collaborate with Central Site Services in the development of the templates for the investigator contract and budget, and investigator Grant payments process. - Team with cross functional team members (i.e., Data Management (DM), Clinical Science (CS) and Biostats) in protocol deconstruction eCRF (Electronic Case Report Form) development, the development and review of the data management plan, edit specifications, eCRF completion guidelines, diaries, questionnaires, and data screens. - Throughout the course of the project, monitor and QC the electronic Trial Master File (eTMF) to ensure that the required trial documentation is filed per the TMF reference model. - At study close out responsible for oversight and transfer of a quality eTMF to the sponsor. - Collaborate with internal team, sponsor, medical monitor, and partners to develop agenda and content of the project team meetings. - Lead the project, site, internal and vendor meetings and ensure meeting minutes and action items are captured, distributed to all team members, sponsor, and management. - In collaboration with CS and DM review and identify study data for trends (per company process) and in collaboration with the internal team develop a plan (retraining of sites etc.) to address any issues or concerns with the data collection/data entry. - Participate as needed in data review meetings in collaboration with DM, CS and Biostats, internally and with the sponsor to review data for trends or issues and develop an action plan to address any questions or concerns. - Monitor the quality of vendor deliverables, address any issues with the appropriate team members and identify opportunities to improve training, execution, and quality across the team. Responsible for oversight of any changes to the study because of a protocol amendment as per the SOW. This includes ensuring study related documents (i.e., Amendment, ICFs, manuals, plans, eCRF, eCRF completion guidelines and contracts) are updated and distributed/communicated to the internal and external team and vendors in a timely manner. - Responsible for oversight of Corrective and Preventative Action Plan (CAPA) process implementation as needed for assigned trials. Collaborates with cross functional teams, Clinical Operations Management and Quality Management on CAPA plan, process, and implementation. - Responsible to review and provide input to corrective and preventative actions for Internal Quality Review (IQR) findings for assigned studies and works with Clinical Operations Management to address findings. - Facilitate and assist Medical Writing in the development of the Clinical Study Reports (CSRs). - Maintain proficiency to current ICH and GCP regulations, guidelines, and white papers as they apply to areas of study. Position Qualification Requirements: Education: Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required. Experience: Minimum of 8 years’ experience with clinical research methodology and product development activities (IND filing, study design, monitoring, study coordination, data management, data analysis, NDA submissions) and prior project management or project lead coordination experience. Required Certifications: N/A Required Skills: - Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners. - Exceptional attention to detail and timelines. - Demonstrated track record in leading successful teams to achieve aggressive timelines using creative problem-solving techniques. - Collaborative leadership style. - Preferred experience in bid defense process - Ability and willingness to travel as needed. - Proficient with Microsoft Office Suite. - Excellent written and oral communication skills. - Strong organizational, problem-solving, and analytical skills. - Versatility, flexibility, and a willingness to work within constantly changing priorities. - Proven ability to handle multiple projects and meet deadlines. - Ability to deal effectively with a diversity of individuals at all organizational levels. - Commitment to excellence and high standards. - Ability to work independently and as a member of various teams and committees. - Good judgement with the ability to make timely and sound decisions.

As a Project Manager you are a key member of the Development Operations, Project Management Team. You are accountable for achieving successful delivery of clinical trial team activities at the trial/program level by meeting contractually agreed sponsor and regulatory requirements according to Scope of Work (SOW) and agreed upon timelines. You will lead and direct cross functional teams and understand/manage sponsor expectations. You will proactively identify, resolve/mitigate, and escalate risks and/or issues. Position Responsibilities/Accountabilities: - Responsible for planning, tracking and delivery of efficient and high-quality trial execution of all operational aspects of assigned clinical trials/programs (can be more than one) from protocol inception through Clinical Study Report and trial close out. - Responsible to manage and drive the SOW consistent with the targeted timelines and budget for the assigned clinical trials/programs. - Responsible for communication to the sponsor with strict attention to budget and timeline estimates for deliverables and timely notification of changes to SOW and timelines. - Responsible for timely communications to the sponsor on all aspects of the study with a priority on communicating any patient safety issues. - In collaboration with the trial/program team and all stakeholders ensures the completion of all project deliverables from contract signature to delivery of final clinical study report and project close out complying with ICH GCP requirements. - Responsible to manage study vendors, patient enrollment and liaise with investigators and study sites. - Lead cross-functional teams while understanding and managing client expectations. - Responsible for working with the sponsor, subcontractors and Catalyst assigned project team members to manage resources (internal and external) to meet contracted project timeline and sponsor expectations. - Responsible to proactively identify, resolve/mitigate, and escalate risks or issues when necessary and proactively communicate to the project team any issue that may negatively impact the overall project, seeking a collaborative resolution. - Continually look for methods to improve the overall collaboration, efficiency, and excellence with which the deliverables are achieved. - Perform project status tracking and reporting including participation in the monthly project review with the ELT. - Accountable for the overall integration and communication of the study parameters to all stakeholders/partners (sub-contractors, strategic partners, internal partners, and Sponsor representatives) to ensure the execution of the work product. - Ensure effective project plans (i.e., Clinical Monitoring Plan, Communication Plan, Project Management Plan, Vendor Oversight Plan, Recruitment Plan) are developed and in place and optimal for the trial as per SOW and company Standard Operating Procedures (SOPs). - Work proactively with the clinical trial team to set priorities in accordance with applicable project plan, company SOP and procedures, International Conference on Harmonization-Good Clinical Practice (ICH/GCP) guidelines and regulatory requirements. - Responsible for oversight of the Clinical Monitoring Plan to ensure a consistent approach to monitoring is maintained throughout the study. - Per SOW collaborate with internal safety team member or Safety Vendor to develop Safety Management Plan and ensure the internal and extended team members are trained on the plan. - Proactively report project resource needs to management (overage as well as shortage). - Contribute to the development of site initiation presentations and in collaboration with the Clinical Research Associate (CRA) and sponsor deliver to sites for initiation purposes. - Provide project/trial level input and coordination of tasks supporting the following deliverables: feasibility analysis, recruitment projections, data collection status, data cleaning progress and strategy, data lock tracking and overall reporting of deliverable timelines. - Develops and revises trial and site recruitment strategies/plan to support achieving the recruitment goal as driven by project milestones. - Collaborate with Central Site Services in the development of the templates for the investigator contract and budget, and investigator Grant payments process. - Team with cross functional team members (i.e., Data Management (DM), Clinical Science (CS) and Biostats) in protocol deconstruction eCRF (Electronic Case Report Form) development, the development and review of the data management plan, edit specifications, eCRF completion guidelines, diaries, questionnaires, and data screens. - Throughout the course of the project, monitor and QC the electronic Trial Master File (eTMF) to ensure that the required trial documentation is filed per the TMF reference model. - At study close out responsible for oversight and transfer of a quality eTMF to the sponsor. - Collaborate with internal team, sponsor, medical monitor, and partners to develop agenda and content of the project team meetings. - Lead the project, site, internal and vendor meetings and ensure meeting minutes and action items are captured, distributed to all team members, sponsor, and management. - In collaboration with CS and DM review and identify study data for trends (per company process) and in collaboration with the internal team develop a plan (retraining of sites etc.) to address any issues or concerns with the data collection/data entry. - Participate as needed in data review meetings in collaboration with DM, CS and Biostats, internally and with the sponsor to review data for trends or issues and develop an action plan to address any questions or concerns. - Monitor the quality of vendor deliverables, address any issues with the appropriate team members and identify opportunities to improve training, execution, and quality across the team. Responsible for oversight of any changes to the study because of a protocol amendment as per the SOW. This includes ensuring study related documents (i.e., Amendment, ICFs, manuals, plans, eCRF, eCRF completion guidelines and contracts) are updated and distributed/communicated to the internal and external team and vendors in a timely manner. - Responsible for oversight of Corrective and Preventative Action Plan (CAPA) process implementation as needed for assigned trials. Collaborates with cross functional teams, Clinical Operations Management and Quality Management on CAPA plan, process, and implementation. - Responsible to review and provide input to corrective and preventative actions for Internal Quality Review (IQR) findings for assigned studies and works with Clinical Operations Management to address findings. - Facilitate and assist Medical Writing in the development of the Clinical Study Reports (CSRs). - Maintain proficiency to current ICH and GCP regulations, guidelines, and white papers as they apply to areas of study. Position Qualification Requirements: Education: Minimum of a BS/BA in a biomedical discipline or equivalent education/training is required. Experience: Minimum of 5 years’ experience with clinical research methodology and product development activities (IND filing, study design, monitoring, study coordination, data management, data analysis, NDA submissions) and prior project management or project lead coordination experience. Required Certifications: N/A Required Skills: - Demonstrated proficiency in communicating with and motivating multiple partners/vendors/outsource partners. - Exceptional attention to detail and timelines. - Demonstrated track record in leading successful teams to achieve aggressive timelines using creative problem-solving techniques. - Collaborative leadership style. - Preferred experience in bid defense process - Ability and willingness to travel as needed. - Proficient with Microsoft Office Suite. - Excellent written and oral communication skills. - Strong organizational, problem-solving, and analytical skills. - Versatility, flexibility, and a willingness to work within constantly changing priorities. - Proven ability to handle multiple projects and meet deadlines. - Ability to deal effectively with a diversity of individuals at all organizational levels. - Commitment to excellence and high standards. - Ability to work independently and as a member of various teams and committees. - Good judgement with the ability to make timely and sound decisions.

As a Clinical Scientist you are a key member in the Clinical Oncology Operations, Clinical Science Team. Your main responsibility is to review, understand, and assess clinical data before it is reviewed by Medical/Client. You will also communicates and present the relevant trends and findings of the clinical review to the Study Team and the Client. You will be working closely with the Study Team, you will ensure that the clinical database and regulatory projects, such as Clinical Study reports (CSRs), maintain the highest level of integrity. Additionally, you will collaborate with the Client, subcontractors, and Catalyst assigned Study Team members to meet project timelines and Client expectations for the clinical data review. You will also assists in the review of CRFs, data quality review plans, and other clinical study reports, among other tasks as needed. You may propose methods to improve collaboration, efficiency, and excellence in data-related review deliverables to the Chief Scientific/Medical Officer, Clinical Operations and Biometry. Position Responsibilities/Accountabilities: • Partner with the Study Team in the development of data review plans for individual clinical studies. • Collaborate with appropriate Study Team members (e.g., Medical, Statistics) to ensure the specific protocol defined variables are reported/collected appropriately. • Provide continuous review and interpret relevant clinical data inclusive of efficacy and safety endpoint related data, across various formats such as listings and visual analytics, applying clinical expertise to derive meaningful insights. • Participate in tracking/analysis of any potential safety events within a given trial and across trials for assigned program(s). • Responsible to communicate and present the pertinent trends/findings of the clinical research to the Project Medical Monitor or designee, Study Team, and the Client as relevant. • Contribute to discussions with the Study Team and/or Client regarding modifications in the study and/or strategy based on the clinical review of the study data. • Create data summary slides as applicable for Safety Review Committee Meetings (SRCs), DSMBs, and Catalyst Data Review Meetings. • Collaborate with Study Team members (e.g., Project Managers, Project Medical Monitor, CRAs, Biometry) and any third-party vendors to ensure accurate reporting and collection of protocol defined endpoints, and associated data. • Partner with Data Management on CRF design, instructions for unique CRFs and CRF completion guidelines. • Create queries on EDC data as needed during Clinical review, provide timely follow up and identify potential protocol deviations on a clinical study. • Assist in the development of study-specific listings as needed on a project to supplement clinical analytic dashboards. • Point of contact for site staff and monitors regarding study protocol and clinical inquiries, as needed. • Review and contribute to Study Management Plans as needed, such as Safety Review Committee Charter. • Collaborate with and Perform informal UAT testing for project level Clinical analytic dashboards prior to production release. • Review and provide input on data driven sections of reporting documents, such as INDs, BLA/NDAs, Annual Report, IBs, briefing books, CSRs, IMPDs, etc., as directed by Manager. • Mentor and/or train staff. • Provide scientific writing for such projects as subject/patient narratives or non-regulatory documents such as abstracts, posters, and oral presentations, as directed by Manager. • Fluent in Visual Analytics interpretation Position Qualification/Requirements: Education: Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) preferred. Experience: 8 or more years of industry/related experience OR Bachelor’s degree in a life-science or nursing with 12 years or more of industry/research related experience including reviewing and interpreting data. Required Skills: • Extensive and direct knowledge of the clinical development process as well as principles of study design. • Comprehensive understanding of product and safety profiles. • Experience in the principles and techniques of data analysis, interpretation, and clinical relevance. • Experience with electronic data capture systems and data visualization tools •Well-versed in GCP, ICH, and relevant regulatory requirements. • Proficient with Microsoft Office Suite, inclusive of Excel, PowerPoint, Word. • Excellent written and oral communication skills. • Excellent presentation skills. • Strong organizational, problem-solving, and analytical skills. • Ability to manage priorities and workflow. • Versatility, flexibility, and a willingness to work within constantly changing priorities. • Proven ability to handle multiple projects and meet deadlines. • Strong interpersonal skills. • Ability to deal effectively with a diversity of individuals at all organizational levels. • Commitment to excellence and high standards. • Creative, flexible, and innovative team player. • Ability to work independently and as a member of various teams and committees. • Good judgement with the ability to make timely and sound decisions. • Willingness to travel to various meetings or Client sites, including overnight trips

As the Vice President, Biostatistics & Programming, you will be responsible for the strategic leadership, delivery, development, and oversight of the global Biostatistics & Programming department. This position provides daily supervision of and establishes operational framework for the global Biostatistics and Programming department. You will be responsible providing executive direction in planning, analyzing, and summarizing the results of individual clinical studies or groups of studies (integrated summaries). You will also coordinate the development and review of regulatory submissions (e.g., NDAs) in accordance with Standard Operating Procedures (SOPs) or study-specific guidelines. You will oversee the implementation of departmental strategies and initiatives, evaluate key performance indicators, participate in business development activities, and provide financial oversight of the department. You will have full responsibility for the effective recruitment, retention, and development of biostatistics and programming staff. This position serves as a key member of the Worldwide Flex Leadership Team. Position Responsibilities/ Accountabilities: - Provide executive oversight on multiple clinical research projects and client relationships. - Provide senior management support for broad-based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations. - Provide advanced technical expertise, in conjunction with internal and external team members, to design, implement, validate, and maintain project reporting applications that are supported by the department. - Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events. - Set strategy, develop, lead, and oversee the global department. - Develop and track metrics on productivity and quality, and create strategies and best practices. - Hire, supervise, and mentor biostatistics and programming leaders to effectively manage projects and staff. - Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables. - Drive commercial growth for the business and partner with commercial colleagues effectively. - Provide strategic input to technology for current and future state. - Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner. - Oversee operational execution of biostatistics and programming activities within the scope of the contract. - Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. Act as a point of escalation as needed. - Provide financial oversight for the Biostatistics and Programming department. - Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments). - Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance. - Review and approve non-billable travel requests for the data management team and maintain department utilization. - Act as a biostatistics and programming champion within the company. Managerial Requirements/ Responsibilities: ​Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary. Position Qualification Requirements: Education: Master’s degree, equivalent, or higher in biostatistics or a related field. A satisfactory combination of education and experience may be accepted as a substitute for the specific education and experience listed above. Experience: - A minimum of 15+ years of relevant work experience - A minimum of 7+ years of biostatistics and programming line management experience. - Previous experience in a pharmaceutical research or CRO setting required. - Previous experience in multiple therapeutic areas. Required Certifications: N/A Required Skills: - Knowledge of clinical trial study design and multiple therapeutic areas, including oncology. - Advanced knowledge of SAS and other specialist software. - Able to work independently and direct various teams and committees. - A high degree of accuracy and attention to detail. - Proficient with Microsoft Office Suite. - Excellent written and oral communication skills. - Excellent presentation skills. - Strong organizational, problem-solving, and analytical skills. - Ability to manage priorities and workflow. - Versatility, flexibility, and a willingness to work within constantly changing priorities. - Proven ability to handle multiple projects and meet deadlines. - Strong interpersonal skills. - Global communication and time zone awareness. - Ability to work effectively with a diversity of individuals at all organizational levels. - Commitment to excellence and high standards. - Creative, flexible, and innovative team player. - Ability to travel for meetings or training activities. - Ability to travel internationally may be required. - Develop and guide implementation of departmental objectives and strategies. - Proven ability to effectively manage and mentor junior staff. - Ability to effectively engage with executive leadership. - Experience with financial and budget management. - Commercial experience Physical Demands (US ONLY): Sedentary work that primarily involves sitting/standing. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.

As the Vice President, Data Management, you will be responsible for the strategic leadership, delivery, development, and oversight of the global Data Management department. You will provide daily supervision and establish operational framework for the Global Data Management department. You will be responsible for providing executive oversight and development of personnel, processes, and SOPs for the global data management department. They act as an executive oversight, ensuring delivery execution and leading teams with a goal of real-time, efficient data flow, leading to a clean, analyzable database. They will oversee the implementation of departmental strategies and initiatives, evaluate key performance indicators, participate in business development activities, and provide financial oversight of the department. They act as the company lead for efficient data flow to ensure compliance with client and regulatory audits. You will have full responsibility for the effective recruitment, retention, and development of Data Management staff. You will be a key member of the Worldwide Flex Leadership Team. Position Responsibilities/Accountabilities: - Set strategy, develop, lead, and oversee global data management department. - Develop and track metrics on productivity and quality, and create strategies and best practices. - Hire, supervise, and mentor data management leaders to effectively manage projects and staff. - Develop and maintain Standard Operating Procedures and other departmental processes and procedures in accordance with guidelines and regulations to ensure quality deliverables. - Provide strategic input to business development activities, such as capabilities/bid defense presentations and Requests for Proposals (RFP’s). - Provide strategic input to technology for current and future state. - Develop study-specific bids that demonstrate an understanding of each client’s needs in a creative, innovative, efficient, and effective manner. - Oversee operational execution of data management activities within the scope of the contract. - Maintain an awareness of project issues and support teams as needed to maintain a positive relationship with clients. Act as a point of escalation as needed. - Provide financial oversight for the Data Management department. - Develop and track metrics on productivity and quality, and create strategies and best practices. - Develop and oversee departmental staff (activities to include interviewing, terminations, promotions, training, personnel growth and retention plans, performance appraisals, goal setting, and salary adjustments). - Supervise and mentor reporting staff in tasks and activities to develop the team structure and enhance departmental and project performance. - Represent the department and company in a multi-disciplinary setting, including project team meetings, client meetings/presentations, bid defense meetings, and be on the podium at industry events. - Review and approve non-billable travel requests for the data management team and maintain department utilization. - Act as a data champion within the company. Managerial Requirements/ Responsibilities: Position will have management responsibilities. Development, oversight, and direction of departmental staff which may include interviewing, terminations, training, personal growth, retention plans, coaching/performance management, goal setting, & salary. Position Qualification Requirements: Education: Degree in statistics preferred; however, a degree in science, mathematics, or a related field coupled with relevant work experience may be an acceptable substitute. Experience: - A minimum of 15+ years of relevant work experience. - A minimum of 5 years of relevant leadership experience in a Clinical Research Organization with extensive exposure in business development and management activities. Required Certifications: N/A Required Skills: - Strong working knowledge of the drug development process, ICH GCP guidelines, and FDA and/or international regulations and their application to clinical trials. - Data management acumen and industry awareness. - Strong knowledge of budgeting, forecasting, and resource management. - Strong computer skills and working knowledge of a wide range of computer applications. - Proficient with Microsoft Office Suite. - Excellent written and oral communication skills. - Excellent presentation skills. - Strong organizational, problem-solving, and analytical skills. - Ability to manage priorities and workflow. - Versatility, flexibility, and a willingness to work within constantly changing priorities. - Proven ability to handle multiple projects and meet deadlines. - Strong interpersonal skills. - Ability to deal effectively with a diversity of individuals at all organizational levels. - Commitment to excellence and high standards. - Creative, flexible, and innovative team player. - Ability to work independently and as a member of various teams and committees. - Good judgement with the ability to make timely and sound decisions. Physical Demands (US ONLY): Sedentary work that primarily involves sitting/standing. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa.