Precision Medicine Group

• Review, draft, negotiate and track a variety of legal agreements including confidentiality disclosure agreements (CDA), initial clinical trial agreements (CTA), amendments to the clinical trial agreements (CTA-A), site budgets and other various types of documents • Work closely with the Clinical Operations study team and play an administrative role to ensure deliverables are in alignment with defined project timelines and expectations • Prepare and negotiate Agreements/Amendments such as Confidentiality Disclosure Agreements (CDA), Clinical Trial Agreements (CTA) and Amendments (CTA-A), vendor contracts and site budgets • Lead interactions with the North American and European internal study teams, as applicable • Lead interactions regarding the various agreements with the Site(s) • Lead interactions regarding assigned agreements with the Sponsor(s) • Work with supervisor and various internal/external stakeholders to resolve contractual issues • Ensure adhered to company policies, procedures, and contracting standards • Update relevant study team members and sponsors regarding the status of contract negotiations and execution • Coordinate execution of the agreements • Support the maintenance of contract files and databases, including email and document archiving • Other duties as assigned

• Manage communications with team members regarding initial/ongoing information and status. • Assist Client Services team to support the development of new business initiatives, identifying opportunities for organic growth within your assigned account • Coordinate pitch presentations and request for proposals. • Lead point of contact for assigned projects within the client account • Implement projects to promote and ensure the success and profitability of your client's deliverables. • Support client services' efforts by managing projects, collaborating with the Project Management team to develop timelines, communicate milestones and identify possible red flags in projects. • Drive the daily activities of a project by managing project scope, scope change, and potential project roadblocks, according to timeline and budgets. • Coordinate and participate in content planning meetings with key content experts. • Daily client contact, prepare client contact reports and summarize next steps. • Facilitate the medical-legal-regulatory review process to ensure promotional items adhere to medical/regulatory/legal compliance. Contribute to the creation of client proposals, budgets and reconciliations and monitor budget including direct/labor costs; checking for out of scope items and hours • Assist with financial and forecasting reporting preparation

• Serving as medical point person on assigned accounts • Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas • Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas • Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.) • Working closely with account teams to refine content in keeping with strategic imperatives • Communicating medical content with internal team and pharmaceutical clients, as necessary • Attending medical, legal, regulatory review meetings • Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings • Chipping in ideas for new business proposals and tactical planning within assigned accounts • Mentoring junior level writers

• Develop, mentor, coach and manage CTMs, and PCTMs to progress their skillset as per Precision for Medicine quality standards. Advocate individual growth and career development • Work with the Clinical Operations Management Team and management of other functional areas to continually improve and enhance CTM expectations and procedures to promote quality, consistency and efficiency while achieving established Key Performance Indicators (KPIs) • Collaborate with the Resourcing team to ensure Clinical Operations resource allocations and needs are appropriately met • Generate action plans and provide developmental/strategic oversight to optimize CTM services, with a focus on high quality delivery of individual/team/departmental goals • Provide on-going feedback and development to manage the performance of direct reports • Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals, and deliverables) to assigned CTMs • Ensure all assigned CTMs have the proper resources, training, materials, and access to systems to deliver on the expectations of their position • Ensure CTMs uphold high quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements • Ensure CTMs provide timely and accurate updates of all required administrative material (SOPs, T&E, etc.) on company systems. • Recognize, exemplify, and adhere to Precision’s values that center on our commitment to quality, our people, clients, and performance • Perform other duties and departmental initiatives as assigned by Leadership

• Responsibilities will include, but may not be limited to; safety management plan development, serious adverse event (SAE, SUSARS) case management from intake to regulatory reporting, and providing safety expertise in a timely manner upon request from team members, clients, and study site personnel. • Interfacing with sponsors, vendors, and other internal team members in the area of safety to assist in the design and implementation of safety collection tools, processes, and reporting systems. • Participate in the assessment and set-up of a safety database to capture SAE data. • Perform intake, triage, data entry, medical coding, expectedness assessment, and composition of narratives and analyses of similar events for individual case safety reports (ICSRs), while following applicable regulations and company policies and procedures. • QC of documents and safety reports. • Preparation and/or review of project-specific safety reporting plans and medical coding plans. • Preparation and/or review of safety training materials. • Provide safety training and oversight for consultants, contractors and/or staff. • Review and/or draft standard operating procedures and work instructions. • Assist clients and/or other departmental staff with safety-related reviews and other services. • Other duties as assigned.

Role Description Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements. - Primary clinical point of contact with the client - Collaborate with PM on monthly invoicing and variance management of clinical budget - Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) - Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings - Generate potential site list from key stakeholders and drive site feasibility process - Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment - Develop and finalize the country recruitment/retention strategy - Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures - Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs - Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate - Support in planning and conducting investigator meetings - Review and/or approve of IP release packages - Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable - Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables - Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate - Responsible for eTMF implementation and management - Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure - Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits - Work closely with PM for project-specific resourcing issues - Escalate pertinent CRA performance and site compliance issues when necessary - Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines - Manage processes for investigational product (IP) including drug accountability and reconciliation - When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed - Support business development and marketing activities as appropriate - May negotiate site budget and investigator contract with support from the legal department and/or site contracts group - May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan - May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM - May perform clinical data review of patient profiles, data listings and summary tables, including query generation - May have line management responsibilities - Performs other duties as assigned by management Qualifications - Minimum Required: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred - Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience - Preferred: Advanced degree - Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) - Excellent communication and interpersonal skills to effectively interface with others in a team setting - Excellent organizational skills, attention to detail, and a customer service demeanor - Ability to travel domestically and internationally including overnight stays Requirements - Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement - Working knowledge of clinical management techniques and tools - Direct work experience in a cross-functional environment - Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics - Proven experience in planning, risk management and change management - High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective - Ability to lead and inspire excellence within a team - Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency - Results oriented, accountable, motivated and flexible - Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills - Excellent presentation, verbal and written communications skills - In depth proven experience in pharmaceutical and/or device research required - Demonstrated successful independent negotiation and conflict management strategies Benefits - Compensation range: $110,700 — $200,900 USD - Discretionary annual bonus - Health insurance - Retirement savings benefits - Life insurance and disability benefits - Parental leave - Paid time off for sick leave and vacation

Role Description The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. - Serve as primary point-of-contact and primary escalation point to the client. - Coordinate and oversee all functional services including external vendors to the established timeline and budget. - Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. - Independently drive the CO to completion and execution with support as needed. - Maintain integrated collaboration with clinical operations in the delivery and participate in clinical activities as appropriate. - For projects of very limited scope, Sr. PM may assume all clinical activities. - Manage the financial health of assigned studies, including oversight of project profitability, billable project hours, and compliance with on-time, accurate billing and forecasting. - Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation. - Ensure quality management for assigned projects, including eTMF Inspection readiness and implementation of quality notification incident forms. - Maintain integrated collaboration with all functional operations in the delivery of the program. - Establish tracking metrics to monitor trial and team progress towards project goals. - Prepare project status updates and report on progress to clients and senior management. - Lead both internal and client meetings and set expectations for the project team. - Communicate effectively with client and Precision management to relay protocol/study issues. - Ability to conduct formal presentations to a wide variety of audiences. - Ensure study specific training is implemented in collaboration with functional areas. - Support business development and marketing activities as appropriate. - Perform other duties as assigned by management. - Remain compliant with organizational training, time-reporting, and any other administrative duties. - Provide ongoing feedback for functional team members including annual performance reviews. Qualifications - North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred. - EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred. - Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience. - Experience in managing complex and global trials. - Ability to travel domestically and internationally including overnight stays. Requirements - Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC, and CTMS. - Proven communication and interpersonal skills to effectively interface with others in a team setting. - Proven organizational skills, attention to detail, and a customer service demeanor. Competencies - Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items. - Direct work experience in a global, cross-functional project management environment. - Good understanding of cross-functional management. - Good understanding of project planning, risk management, and change management with an awareness of appropriate escalation. - Proven experience in strategic planning, risk management, and change management. - High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective. - Ability to lead and inspire excellence within a study team. - Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency. - Results-oriented, accountable, motivated, and flexible. - Proven time management, negotiation, critical thinking, decision making, analytical, and interpersonal skills. - Proven presentation, verbal, and written communications skills. - Good understanding of project management software. - In-depth proven experience in pharmaceutical and/or device research required. - Preferred: experience with oncology & cell and/or gene therapy. Benefits - Discretionary annual bonus. - Health insurance. - Retirement savings benefits. - Life insurance and disability benefits. - Parental leave. - Paid time off for sick leave and vacation.

• Process ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory reportability • Enters data into Argus Safety Database • Code events, medical history, concomitant medications and tests • Draft case narratives • Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases • Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects • Participates in audits/inspections as required • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process

• Provide overall support to study sites and clinical project teams engaged in clinical research studies • Adhere to applicable protocols, standard operating procedures (SOPs) and all applicable guidelines and regulatory requirements (e.g., International Council for Harmonization (ICH), Good Clinical Practice (GCP), and country/region-specific regulations) • Act as point of contact for study sites • Assist with the investigator recruitment activities utilizing phone scripts, questionnaires, study site materials and other tools for use in evaluating investigative sites • May assist in identifying study sites by performing site feasibility and recruitment tasks • Schedule internal and external meetings as required • Prepare Investigator Site Files including distribution to study sites (electronically or physically), coordination with shipping vendor, if required • Perform ongoing essential document collection and review, maintenance, and close-out activities, organizing and maintaining site level data • Ensure timely and complete data entry by site in EDC or any other system that requires data entry • Document site and Sponsor contact and study interactions in a timely and professional manner

• Develop, negotiate global study budgets based on the requirements of a study protocol. • Review, draft and negotiate a variety of agreements including confidentiality agreements, master confidentiality agreements, clinical study agreements and amendment agreements • Work with supervisor and various internal/external key stakeholders to resolve/escalate contractual issues • Ensure adherence to company policies, procedures and contracting standards. • Update relevant study team members regarding the status of contract negotiations and execution. • Coordinate execution of agreements • Support the maintenance of contract files and databases, including contract archiving. • Recognize where processes can be improved and take corrective action.