We are seeking a Senior Clinical Data Manager with a keen attention to detail who will be responsible for overseeing the start-up and execution of several trials with a CRO and additional support with upcoming submissions. The individual will coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.
- Serve as Lead CDM to manage and provide daily oversight of CROs and third-party vendors in relation to DM to ensure successful clinical trial implementation and execution to completion.
- Review data for protocol deviation identification, as well as coding, and user acceptance testing of database.
- Review documents produced by vendors and other departments.
- Work cross-functionally with other departments within the company assessing and understanding their needs.
- Strategize and plan for database locks and multiple deliverables across numerous programs.
- Provide input on the development of standard operating procedures (SOPs) and study protocols from a data management perspective.
- Set-up, maintain and archive data management related project documentation (i.e., Data Management Plan, CRF Completion Guidelines, etc.).
- Ensure project is in reasonable state of inspection readiness and compliance.
- Experienced in designing clinical trials utilizing CDASH and SDTM standard terminology.
- Strong technical skills and experience with managing system integrations across data platforms.
- Adhere to budgets and timelines.
- Work with minimal supervision.
- Bachelor’s degree in life science, pharmacy or related field. Equivalent combination of education and applicable job experience may be considered.
- Minimum 4 years of direct Data Management experience required.
- Prior clinical trial vendor management preferred.
- Experience in managing outsourced studies and working for a CRO are preferred.
- Recent experience in cleaning data required.
- Knowledge of drug development process.
- Understanding of ICH Guidelines and GCP Requirements.
- Demonstrate initiative, sound judgement, and flexibility; possess effective time management and organizational skills; and capable of working on multiple projects simultaneously under tight timelines or heavy stress.
- Ability to develop and maintain timelines.
- Demonstrates ability to interact professionally with personnel at all levels within and external to the company and be dependable and a team player.
- Demonstrates project management skills (i.e. plan, organize, and manage activities to deliver specific study goals and objectives to measurable targets).
- Accountability – Even in ambiguous circumstances, always demonstrate ownership for decisions and actions.
- Ability to travel as necessary (approximately 10%).
- Well-versed in different EDC Systems.
- Excellent communication skills and interpersonal skills.