The Clinical Data Manager will be responsible for performing Data Management activities that support Jazz Pharmaceuticals’ 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.
The Clinical Data Manager will:
- 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 Jazz Pharmaceuticals Code of Business Conduct and Ethics
- Assist with the training of new employees and/or contractors
- BA/BS, preferably in the scientific/healthcare field.
- 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.
- Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Possesses strong English language written and verbal communication skills.
- Experience and understanding of the Oncology or CNS therapeutic area, and with Phase III pivotal studies are desirable.
- Able to travel to off-site meetings or training seminars as needed.
- Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems is desirable.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.