Senior Data Manager
Clinovo
- Palo Alto, California, United States
- Palo Alto, California, United States
Über
Role 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.
- 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.
Sprachkenntnisse
- English
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