About this role
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is hiring for multiple Clinical Data Manager positions in 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:
• 5+ 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.