Senior Data Manager

Senior Clinical Data ManagerRole Overview The Senior Clinical Data Manager will play a critical role in database development, data quality oversight, and vendor coordination to ensure accurate, compliant, and submission-ready clinical trial data. This role requires strong hands-on expertise and a collaborative mindset, working closely with cross-functional teams to support successful trial execution and regulatory submissions. Key Responsibilities Support the design, development, testing, and validation of clinical trial databases and electronic Case Report Forms (eCRFs) at the study level. Oversee data cleaning activities, query generation and resolution, and the delivery of high-quality datasets aligned with study timelines and milestones. Collaborate with external data management vendors to ensure timely, accurate, and high-quality deliverables; monitor vendor performance against project timelines and quality standards. Participate in the preparation, review, and validation of submission-ready datasets to support regulatory filings (e.g., NDA, BLA, MAA). Ensure compliance with applicable regulations and industry standards, including GCP, FDA, EMA, and ICH guidelines. Support audit and inspection readiness by maintaining documentation and participating in regulatory inspections as needed. Coordinate with internal stakeholders, including Clinical Operations, Biostatistics, Regulatory Affairs, and IT, to ensure seamless data integration, reporting, and analysis. Contribute to the implementation, optimization, and ongoing improvement of clinical data systems and tools (e.g., EDC platforms, data review and visualization tools). Identify and proactively resolve data-related risks and issues throughout the study lifecycle. Education & Qualifications Bachelor's degree in Life Sciences, Data Science, Computer Science, or a related discipline. 7+ years of experience in clinical data management within a biotech, pharmaceutical, or CRO environment. Demonstrated experience managing study-level data management activities from study start-up through database lock. Proven experience working with and overseeing external data management vendors. Strong familiarity with clinical data systems such as Medidata Rave, Oracle Clinical, and/or Veeva Vault. Knowledge of industry data standards, including CDISC and SDTM. Experience supporting regulatory submissions is highly desirable. Excellent problem-solving, organizational, and communication skills, with the ability to work effectively in cross-functional teams. Detail-oriented, quality-driven, and comfortable operating in a fast-paced clinical development environment.

Created: 2026-03-04