Everest Clinical Research

Role Description To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Senior Clinical Database Designer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy. - Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities. - Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process. - Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline. Maintain database design timelines and promote good project management practices. - Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities. - Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trials. - Author and review the Data Validation Specifications for assigned projects. - Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers. Coordinate and oversee the UAT process for clinical databases. - Design and review patient Case Report Forms and database schema. Test data capture/entry screens through UAT. - Participate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetings. - Participate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes. - Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems. - Provide input to all data management procedural documents. - Plan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements. - Review the Data Management Plan (DMP) for assigned projects. - Review data, issue and resolve queries. Assist the Lead Data Manager, sponsor or Investigative Site with resolving queries. - Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products. - Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team members. - Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. - Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. - Participate in and contribute to Clinical Data Management initiatives. - Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports. Qualifications - B.Sc. in Biological Sciences or Computer Science. - Five years' related experience. - Two to three years developing Inform and/or Medidata Rave (or similar) clinical databases. Previous Clinical Data Management experience in both paper-based and electronic data capture systems. - Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels. - Proven leadership and interpersonal skills in complex team situations. - Excellent presentation skills and the ability to build relationships with both internal and external clients. - Must be well organized and able to work independently and manage multiple projects/tasks appropriately. - Demonstrated ability to effectively organize and integrate the activities of information processing personnel. Benefits - Robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - 401(k) retirement plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. - Estimated Salary Range: $90,000 - $130,000.

Role Description To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Clinical Database Designer for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy. - Design clinical database for new studies based on requirement specifications in various electronic data capture (EDC) systems, including: - Case Report Forms (CRF) - Edit checks - Study roles - Laboratory - Coder - Randomization and Trial Supply Management (RTSM) - Perform post go-live changes (database modifications) based on updated requirement specifications and provide impact assessment for modifications. - Perform Unit Testing on database design, assist User Acceptance Test (UAT) activities, and address UAT findings. - Set up and configure the development environment for new studies. - Assist the creation of the Database Integration Specification (DIS) with other systems, provide Integration Technical Detail (ITD) as needed, program the integration, and assist the integration test. - Support the Data Manager in investigating and addressing issues related to the database design. - Review study design requirement specifications for assigned projects, ensuring adherence to EDC platform standards and Everest Standards, including: - CRF and Visit Map specification - Data Validation Specification (DVS) - Role Configuration Specification (RCS) - Review the protocol and associated reference material and contribute to the development of the database design project timeline. - Maintain database design timelines and promote good project management practices. - Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process. - Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design. - Participate in EDC vendor’s technical learning and exchange meetings, as well as other internal and external training meetings. - Contribute to the development and maintenance of the company’s database design standard libraries for all EDC systems. - Provide input to all database design-related data management procedural documents. - Cooperate with and assist the Quality Assurance (QA) Department with QA audits on assigned databases. - Validate and disseminate real-time study monitoring reports to Sponsor and internal team members. - Participate in and contribute to Clinical Data Management initiatives. - Design and program tools to assist database design tasks and data management tasks. Qualifications - B.Sc. in Biological Sciences or Computer Science. - One year clinical database design experience, such as developing clinical databases in DFdiscover, InForm, Medidata Rave, Clinical One, and/or other EDC systems. - Software programming experience relevant to the programming languages and design applications in use in clinical research. - Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels. - Excellent interpersonal skills in complex team situations, including the ability to build relationships with both internal and external clients. - Demonstrated ability to effectively organize and integrate the activities of information processing personnel. - Must be well-organized and able to work independently and manage multiple projects/tasks appropriately. Benefits - Medical, dental, and vision coverage - Life & AD&D insurance - Short- and long-term disability - Tuition reimbursement - Fitness reimbursement - Employee assistance program (EAP) - 401(k) retirement plan - Generous paid time off and sick leave - Opportunity to earn a performance-based bonus Company Description Everest Clinical Research (“Everest”) is a full-service, global, contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

Role Description To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as Senior Clinical Database Designer for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy. - Develop new features and functionality within the database design functional areas to increase the efficiency of database design at the study level, and to improve and enhance the company’s database design capabilities. - Assist Clinical Data Management in planning, directing, and managing the clinical database design and maintenance process. - Review the protocol and associated study reference materials to contribute to the development of the clinical database design project timeline. Maintain database design timelines and promote good project management practices. - Follow up on regulatory requirements, industry trends, benchmarking, and best working practices in data management and database design by reading, participating in relevant training and/or relevant association activities. - Design and review case report forms (CRFs/eCRFs) and setup electronic data capture (EDC) systems for clinical trials. - Author and review the Data Validation Specifications for assigned projects. - Develop and review User Acceptance Test (UAT) plans for clinical databases designed by other designers. Coordinate and oversee the UAT process for clinical databases. - Design and review patient Case Report Forms and database schema. Test data capture/entry screens through UAT. - Participate in EDC vendor’s technical learning and exchange meetings as well as other internal and external training meetings. - Participate in trial Investigators Meetings and provide user training to CRAs on how to use EDC systems, and on Dataflow and Quality Control Processes. - Contribute to the development and maintenance of the company’s database design procedural documents, work instructions, checklists and templates for all EDC systems. - Provide input to all data management procedural documents. - Plan, manage, control and perform data processing activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial sponsors’ requirements. - Review the Data Management Plan (DMP) for assigned projects. - Review data, issue and resolve queries. Assist the Lead Data Manager, sponsor or Investigative Site with resolving queries. - Assist in resolving medical coding discrepancies resulting from coding of medical history, adverse events, procedures and medicinal products. - Cooperate with and assist the Quality Assurance Department with quality control audits on assigned databases. Validate and disseminate real-time study monitoring reports to sponsor and internal team members. - Define and monitor clinical trial data flow and quality control processes in accordance to corporate SOPs, Good Working Practices, and unit guidelines. - Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks. - Participate in and contribute to Clinical Data Management initiatives. - Develop and test SAS codes for clinical trial database logical checks and study specific monitoring reports. Qualifications - B.Sc. in Biological Sciences or Computer Science. - Five years' related experience. - Two to three years developing Inform and/or Medidata Rave (or similar) clinical databases. Previous Clinical Data Management experience in both paper-based and electronic data capture systems. - Must communicate effectively, orally and in writing, with personnel on all professional and administrative levels. - Proven leadership and interpersonal skills in complex team situations. - Excellent presentation skills and the ability to build relationships with both internal and external clients. - Must be well organized and able to work independently and manage multiple projects/tasks appropriately. - Demonstrated ability to effectively organize and integrate the activities of information processing personnel. Benefits - Robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - Pension plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. - Estimated Salary Range: $100,000 - $140,000.

• Lead efforts in resolving day to day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations • Provide statistical expertise for design, analysis and reporting of clinical trials and research projects • Develop and/or review ADaM dataset specifications • Perform statistical analysis as per SAP, and address peer/QC review comments and findings • Provide statistical input to Case Report Forms (CRF) design and database/variable structure

• Taking a leadership role in facilitating the efforts of functional area directors and managers in project planning, identification of tasks and deliverables, assessment of resource needs and utilization, and risk identification/mitigation • Ensures that ongoing projects have existing project plans as required by the established Standard Operating Procedures (SOPs) • Ensures that project progress status is tracked and reported, and issues are promptly identified and resolved • Works with functional area directors and managers to be jointly accountable for smooth project start-up, continuation, and successful completion • Interacts with clients for projection of resource requirements and project management purposes • Responsible for defining project scope and estimating budgets, planning, directing, leading project activities, managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities • Accountable for reporting of project progress status to Everest internal management and its clients • May assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP), and subsequently defining scope of work and budgets, and performing contract administration activities

Role Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as a Statistical Programmer II for our Bridgewater, New Jersey, USA on-site location, or remotely from a home-based office anywhere in the USA or Canada in accordance with our Work from Home policy. Key Accountabilities: - Statistical Programming: - Under supervision, may develop and review SDTM and ADaM dataset specifications, annotated Case Report Forms (CRF) and other related documents (e.g., define.xml, reviewer’s guide) based on Statistical Analysis Plan (SAP), Everest company Standard Operating Procedures (SOPs) and Working Instructions (WIs), industry data standards, regulatory requirements, and trial Sponsor-specific requirements. - Program and validate SDTM and ADaM datasets following approved dataset specifications; perform CDISC conformance checks on generated SDTM and ADaM datasets and address conformance findings. - Develop SAS programs to generate and validate statistical output reports of trial data based on the SAP and TLGs mock-up shells. - Provide statistical programming support to Clinical Study Reports, clinical trial efficacy and safety data integrations (Integrated Summary of Safety and Integrated Summary of Efficacy), as well as other data analysis and reporting needs such as regulatory required safety reports (e.g. Development Safety Update Report, 120 Day Safety Update, etc.), ad-hoc requests, and exploratory data analyses. - Clinical Data Acquisition and Cleaning Support: - Develop and maintain SAS programs to perform database integrity checks and work with Data Managers to address data issues and queries for ongoing data cleaning and review. - Support data acquisition of non-CRF data by developing SAS programs to reconcile the CRF and non-CRF data and performing data integrity checks of the non-CRF data. - Develop SAS programs to generate data listings, summary tables, and graphs for ongoing data cleaning and scientific data surveillance reviews (safety, missing data, trending and signaling, etc.). - Develop SAS programs to generate Patient Profiles to support trial subject case review activities. - Document data and programming information in accordance with Everest company SOPs and WIs; and achieve audit readiness during and at the end of the clinical trials for internal and external quality and compliance audits. - Achieve a high rating for each of the defined Everest company and trial Sponsor-specific statistical programming key performance indicators. - Maintain current knowledge of pharmaceutical clinical research industry standards, conventions, and regulatory requirements, as well as the knowledge of clinical trial Sponsor-specific requirements when applicable. - Comply to Everest company-specific and clinical trial Sponsor-specific training requirements. - Develop and provide expertise in other programming and system administration areas when required. Qualifications - A Master’s or Ph.D. Degree in statistics, biostatistics, epidemiology, public health, bioinformatics, mathematics, and computer sciences. - SAS certified Base, Advanced, and Clinical Trials Programmers are highly preferred. - Exposure/experience in clinical trial statistical programming and/or data analysis is desirable. Benefits - Robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage. - Life & AD&D insurance. - Short- and long-term disability. - Tuition reimbursement. - Fitness reimbursement. - Employee assistance program (EAP). - 401(k) retirement plan. - Generous paid time off and sick leave. - Opportunity to earn a performance-based bonus. Company Description Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today. Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

• responsible for working with the Clinical Operations team to deliver high-quality, client-centered, and profitable approaches to clinical startup services • proactively drives projects during the startup phase and interacts with clients as a startup subject matter expert • build and maintain strong client relationships • participate in hiring, training, resource allocation/utilization, performance management, audits, systems, etc. • lead and oversee clinical study startup teams and project start up activities • partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams • actively drive study startup performance across site identification, feasibility, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations • ensure quality and completeness of startup deliverables • monitor project startup timelines, KPIs, cycle times, and quality metrics • provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams • perform business analysis and benchmarking within start up services • drive continuous improvement initiatives across startup operations • author governing documents (SOPs, Checklists, templates, etc.)

• responsible for working with the Clinical Operations team to deliver high-quality, client-centered, and profitable approaches to clinical startup services • proactively drives projects during the startup phase and interacts with clients as a startup subject matter expert • build and maintain strong client relationships and mutually beneficial long-term partnerships • lead and oversee clinical study startup teams and project start up activities • partner with Clinical Operations Leads, Project Managers, sponsors, and cross-functional teams to develop and execute effective startup strategies • actively drive study startup performance across site identification, feasibility, site selection, ethics/regulatory submissions, site activation, contract and budget negotiations, and essential document collection • ensure quality and completeness of startup deliverables by performing reviews of regulatory submissions, essential documents, startup trackers, and study records • monitor project startup timelines, KPIs, cycle times, and quality metrics • provide leadership, mentoring, and line management for Clinical Trial Assistants and Site Contracts/Budgets teams • perform business analysis and benchmarking within startup services and identify opportunities for continuous improvement

• The Senior Project Manager position is responsible for taking a leadership role in facilitating the efforts of functional area directors and managers in project planning • Identification of tasks and deliverables • Assessment of resource needs and utilization • Risk identification/mitigation • Performs overall company-wide project progress tracking utilizing strategic planning and project tracking methods and tools • Ensures that ongoing projects under their scope have existing project plans as required by the established Standard Operating Procedures (SOPs) • Ensures that project progress status is properly tracked and reported • Issues are promptly identified and resolved • Work with functional area directors and managers to be jointly accountable for smooth project start up, continuation, and successful completion • Interact with clients for projection of resource requirements and project management purposes • Responsible for defining project scope and estimating budgets, planning, directing, leading project activities • Managing resources and budgets, as well as project team performance of cross-functional teams engaged in clinical research and development activities • Accountable for reporting of project progress status to Everest internal management and its clients • Activities including, but not limited to site selection, study start-up, clinical operations, statistics, data management, subject randomization and drug supply management (Interactive Web Response Systems [IWRS]), data monitoring and/or adjudication committees, regulatory submissions, vendor management, and medical/scientific writing • When required, assist the organization in responding to and preparing for Request for Information (RFI) and Request for Proposals (RFP) • Defining scope of work and budgets • Performing contract administration activities.

Clinical Site Payments Specialist I Job Category: Project Finance Requisition Number: CLINI002650 - Full-Time - Hybrid - Locations Showing 1 location Sofia, SO 1113, BGR Job Details Description To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our growing team in Sofia, Bulgaria as a full-time Clinical Site Payments Specialist I. This is a hybrid, Sofia based position, for a candidate with an education in finance or economics, and minimum 2 years of prior Clinical Site Payments experience in a CRO (Clinical Research Organization). The Clinical Site Payments Specialist will partner with Project Managers and Clinical Operation Leads to ensure successful processing and management of Clinical Site Payments projects. Key Accountabilities: - Processing site and investigator payment requests and/or invoices with cross functional teams - Creating and maintaining relevant study site payments trackers - Managing internal site payments platform for assigned studies implementation for new studies - Reviewing various site payments data with cross functional teams for quality and completeness - Communicating with internal and external stakeholders and team members - Performing analysis and forecasts of site budgets for existing projects and new proposals - Supporting Business Development in creating high quality clinical site budget estimates Qualifications: - University degree in relevant field: mathematics, economics, business, finance - 2 years prior Clinical Site Payments experience in a CRO (Clinical Research Organization) - Very good written and verbal English - Strong verbal and written communication skills - Strong computer competency, including MS Excel - Organizational and time management aptitude - Ability to operate standard office equipment - Ability to work as part of an international and global team (working across multiple time-zones)