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 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.