Senior Director, Clinical Data Management
142116 Posted : 25th March 2024
- 230000 USD - 285000 USD
- South San Francisco, United States
- Permanent
MEET's client is a growing biotechnology company in South San Francisco. With a rapidly advancing small molecule, clinical-stage pipeline, this company is looking to build out the Biometrics function.
The Head of Clinical Data Management (Senior / Executive Director) will report into the VP of Biometrics and be responsible for building the CDM department from scratch.
RESPONSIBILITIES :
- Supervise CRO data management or contract data management personnel and actively contribute to enhancing clinical data management practices within the company
- Work closely with the clinical team to formulate strategies aimed at enhancing the quality and efficiency of data management
- Ensure that projects adhere to operating procedures and comply with regulatory standards such as GCP, ICH, FDA regulations, and CDISC and FDA submission requirements
- Direct and manage both internal and external clinical data review processes to ensure the completeness, accuracy, and consistency of data in alignment with the data management plan across all ongoing studies
QUALIFICATIONS :
- BS / MS / PhD in Life Sciences
- 12+ years of biotechnology industry CDM experience
- Global clinical trial lead experience is strongly preferred
- In-depth knowledge of clinical trial process, EDC systems (., Medidata Rave, InForm, , programming, clinical operations, quality management, and systems applications
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