Clinical Data Manager (CDM)
The Clinical Data Manager will provide high level of expertise in data management to support all phases of sponsor-developed clinical studies including managing all data management (DM) tasks of complex and/or large studies from start-up through database closure and archival; producing high quality data for analysis and potential regulatory submissions. He/She will serve as point of contact for day to day study activities as lead manager to provide hands on support to study teams and in collaboration with external vendors for multiple clinical trials. The CDM will report directly to VP, Clinical Development.
Essential Duties & Responsibilities:
- Provide preparation, support and review of DM RFPs/proposals and agreements, vet and recommend DM CROs/vendors
- Provide oversight of DM CRO/vendor in collaboration with Clinical Operations to ensure ongoing data quality by ensuring that all DM activities, such as CRF entry, query resolution and DM reporting activities, are completed on time and with quality
- Collaborate and coordinate with internal team members and the CRO/vendor to ensure timely study start-up, maintenance activities and closeout of the database.
- Ensure all project-related data management tasks are completed in accordance with internal and partner quality standards, SOPs, and all pertinent industry/regulatory guidelines and legal requirements from commencement to closure of a project
- Maintain a project-level perspective on data management issues, activities and deliverables (i.e., reviewing protocols and Case Report Forms (CRFs) for cross-project consistency, managing development of project-level standard CRF modules, coordinating data management activities across protocols and within studies to meet overall project deadlines and objectives)
- Serve as a resource for clinical data management strategies, timelines, vendor costs, standards and processes
- Contribute to review of DM-related financial aspects of assigned projects, including the scope, budget, and resource for assigned projects and review of DM -related invoices
- Identify data management project issues and risks and alert Manager with a view to remedial action (i.e., suggested solutions) and serve as point of escalation for individual projects
- Provide early strategic input into protocol design focused on data management issues
- Lead the design and development of database and CRFs by collaborating with other functional area representatives in managing the development of database and CRFs, testing the functionality of the CRFs in the database, and approving release of all aspects into production.
- Review, provide input, and approve the CRO/vendor’s Data Management Plans (setting up primary database structures, data entry screens, etc.) and all applicable DM related documents and plans
- Execute ad hoc database review and provide requested data to project team members
- Develop ad hoc database queries, as necessary
- Perform other related job duties as necessary
- Bachelor degree required; Master degree preferred
- Minimum 7+ years of previous clinical data management or related area of specialization in bio/pharma industry or clinical trials is required
- Experience with Electronic Data Capture (EDC) is required
- Knowledge and proficiency with J-Review preferred
- General knowledge of FDA regulations that govern the execution of clinical trials and EDC systems is essential
- Experience overseeing data management vendors and knowledge of GCP essential
- Proficient in Microsoft Office
- Ability to perform a variety of complicated tasks with a wide degree of creativity, latitude and with deep understanding and wide application of technical principal theories, concepts and techniques
- Independently motivated, detail oriented and good problem solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
- Excellent communications skills, both written and verbal
- Proven ability to thrive in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
Email resumes to firstname.lastname@example.org. Please reference Job ID: Clinical Data Manager (CDM)
Apexigen is an equal opportunity employer