Remote Sr Manager-AD CDM
- R+D/ Global Development Support
- Greater Boston
- Salary range: $130-170k base, bonus + additional benefits
- An exciting clinical-stage biotechnology company pioneering the research and enhancement of innovative multi-targeted interventions to remedy complicated diseases and enhance health is seeking a Sr Manager-AD CDM candidate. The Clinical Data Management is accountable for directly and independently managing clinical data management affiliated with its associated vendors and schedules. The position oversees all priorities and capacity in the CDM department. The position manages intricate clinical data management plans and is accountable for clinical data management tasks to collect, code, process, review, and substantiate clinical trial data obtained in-house and remotely. The position requires the ability to manage projects, vendors and timelines. The position requires endeavors to build, alter, and implement company policies.
The Sr Manager-AD 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.
- Creates and assesses external CDM vendor contracts for project procurement.
- Manage CROs and external vendors team(s).
- Implement new approved technologies and/or systems.
- Serve 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 - Implement and perform versioning; review and approve standard CDASH case report form library and code lists, implemented in EDC.
- Laboratory data standardization and collection - Define global laboratory standards library and reports; perform laboratory data review, standardization, identify data discrepancies and corresponding resolutions
- Lead the clinical project team to develop CRF/eCRF according to CDASH for clinical trials.
- Validate CDM department to ensure audit readiness. Serve as CDM subject matter expert on regulatory audits.
- Develop and finalize global clinical data management SOPs. Develop, modify, and execute 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 8 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.
- Knowledge in developing SOPs
- Involvement 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.
- Understanding 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.
- Validate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
- Able to effectively coordinate personnel, vendors, teams, and projects.