Senior Clinical Data Manager
Vacancy expired!
Overview: Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals. Responsibilities: The Senior 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, lead and execute the Data Management tasks required for phase 1-4 studies. The Senior Clinical Data Manager has a broad, fundamental knowledge of the data management process and is able to perform most required tasks with minimal guidance.The Senior Clinical Data Manager will:
- Be able to lead a large clinical study or a series of related studies with minimal guidance
- Represents Data Management on the CTWG for assigned studies
- Provide mentoring and training to lower level Data Management staff assigned to his/her studies
- Manage and monitor the progress of data management activities with CROs or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts
- 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.
- Lead the development of data edit check specifications and data listings
- 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 or lead the development of 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
- May provide training on the EDC system and/or eCRF Completion Guidelines at Investigator Meetings and to internal and external study team members as needed
- Perform reconciliation of header data from external data sources against the clinical database
- Perform Serious Adverse Event reconciliation activities according to SOPs and guidelines
- Lead database upgrades/migrations including performing User Acceptance Testing
- Be 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; take a leadership role in the development of assigned 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
Vacancy expired!