Sr Clinical Data Manager - Flexible to AD title
- R+D/ Global Development Support
- Greater Boston area
- Salary range: $120k - $175k base, bonus, equity
A clinical-stage biotechnology company establishing the research and development of innovative multi-targeted interventions to treat complex diseases and enhance health. The Clinical Data Management (CDM) is accountable for directly and independently managing clinical data management aligned with its associated vendors and timetables. The position handles all priorities and workload in the CDM department. The position manages intricate clinical data management projects and is responsible for clinical data management tasks to collect, code, process, review, and validate clinical trial data received in-house and remotely. The position requires the ability to manage projects, vendors and timelines. The position requires activities to improve, revise, and implement company policies.
The Sr CDM position will have responsibilities that include:
- Manage CDM vendors, priorities, and workload on the preparation, validation, processing, reviewing, querying, dictionary coding, and maintenance of clinical data on individual clinical trials and regulatory submissions.
- Expands and assesses external CDM vendor contracts for project procurement.
- Manage CROs and external vendors team(s).
- Implement new approved technologies and/or systems.
- Operate as subject matter expert to focus expertise and problem solving strategies on one or more of the following areas below for use across all clinical trials. Lead implementation team(s) appropriately and develop, implement, and version data standards.
- MedDRA and WHO-DD Coding - Implement centralized dictionary coding and dictionary versioning.
- Electronic Data Capture - review and approve screen/system development; expertise on underlying data structure and data storage; manage technical system problems and take corrective action; support ad-hoc report development.
- CDASH - Execute and perform versioning; review and approve standard CDASH case report form library and code lists, implemented in EDC.
- Validate CDM department to ensure audit readiness. Serve as CDM subject matter expert on regulatory audits.
- Create and confirm global clinical data management SOPs. Develop, modify, and complete cross-functional company policies.
The ideal candidate will have the following skill set:
- Requires a Bachelor's degree in a scientific discipline or equivalent
- Minimum experience in clinical data management of 6 years.
- Possess a thorough knowledge of medical terminology; and the clinical data management and the clinical trial process.
- Proficient on regulatory requirements for data management and the regulatory submission process.
- Experience in developing SOPs
- Experience having served as a subject matter expert on regulatory audits.
- Proficient on the design and validation of data collection instruments; the data collection and data review process; data standardization; laboratory data theory, design, and collection.
- Proficient with electronic data capture (EDC) system.
- Proficient with the development of CRF/eCRF for clinical trials and its impact into database design/development.
- Proficient on implementing new data standards, technologies, and systems. Capable of leading implementation teams.
- Proficient on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement.
- Experience in solving extremely complex and increasingly difficult problems, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data.
- Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the company.