Clinical Data Manager - FSP

Description

Summary: The Clinical Data Manager will perform data management activities for commercial and development projects, supporting clinical studies with moderate guidance and collaborating with cross-functional teams. Highlights: 1. Lead or co-lead clinical studies with moderate guidance 2. Manage data management activities with CROs and vendors 3. Collaborate with cross-functional teams for data collection strategies **Parexel FSP is hiring for multiple Clinical Data Manager positions in Colombia, Mexico, Argentina, and/or Brazil.** --------------------------------------------------------------------------------------------------------------------- **Job** **Purpose:** ==================== The Clinical Data Manager will be responsible for performing Data Management activities that support the sponsor’s commercial and development projects worldwide. He/she will participate as an active member of a multi\-disciplinary team to plan and execute the Data Management tasks required for phase 1\-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with moderate guidance **Key** **Accountabilities****:** ================================= * Be able to lead a small clinical study or co\-lead a larger study or studies with moderate guidance * Be able to support several clinical studies with minimal guidance * Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies * Review protocols for appropriate data capture including electronic Case Report Form (eCRF) design. * Be able to perform a thoroughly detailed review of eCRF data requirements. * Interact with CRAs, programmers, study managers and statisticians in designing eCRFs and creating the annotated eCRF and CRF completion guidelines. * Develop data edit check specifications and run data listings as required * Coordinate the design and testing of Electronic Data Capture (EDC) systems according to company standards. Able to resolve EDC system issues with team members * Develop the Data Management Plan for a clinical study. * Able to review and provide feedback to the clinical team on other study documents e.g. Clinical Monitoring plans, Statistical analysis plans and vendor specifications * Enter data queries into the EDC system to be resolved at investigational sites and manage the resolution of those queries * Perform reconciliation of header data from external data sources against the clinical database * Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines * Assist in database upgrades/migrations including performing User Acceptance Testing * Able to maintain study workbooks and data management files * Perform database lock and freeze activities per company SOPs * Participate in regular team meetings and provide input when appropriate * Provide input into the development of data management SOPs, Work Instructions, and process documents * Contribute to a professional working environment including the application of the client’s Code of Business Conduct and Ethics * Assist with the training of new employees and/or contractors * Collaborative relationships * Collaborates with cross\-functional teams to design and implement effective data collection strategies, ensuring high\-quality data capture and timely resolution of data queries throughout the clinical trial lifecycle. * Compliance with Parexel standards * Complies with required training curriculum * Completes timesheets accurately as required * Submits expense reports as required * Updates CV as required * Maintains a working knowledge of and complies with Parexel processes, ICH\-GCPs and other applicable requirements **Knowledge and** **Experience****:** ===================================== * At least two years’ experience in Data Management for the pharmaceutical/biotechnology industry, or equivalent experience in an FDA\-regulated environment * Understands the scope and focus of Phase 1\-4 clinical studies, and has a proven ability to perform some of the core Data Management tasks and interact with vendors. * Possesses an understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidances, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice. * Experience and understanding of the Oncology or CNS therapeutic area and with Phase III pivotal studies are desirable. * Possesses strong English language written and verbal communication skills. **Education:** ============== * Bachelor’s Degree required (Master's Degree preferred) in the scientific/healthcare field. \#LI\-REMOTE