What are the responsibilities and job description for the Associate Director Clinical Data Management Contract position at Meet?
Job Title
Associate Director, Clinical Data Management (Contractor)
Location
Hybrid (South San Francisco, CA)
Duration
6 Months Contract
Company
Mid-Size Biotechnology Company
Job Overview
We are seeking an experienced Associate Director of Clinical Data Management (CDM) for a 6-month contractor role. Based in South San Francisco with a hybrid work setup, this individual will lead Phase I and clinical pharmacology studies , ensuring data quality and integrity throughout the clinical trial lifecycle.
Key Responsibilities
- Lead Data Management for Phase I & Clinical Pharmacology Studies
Oversee clinical trial data management activities for early-phase trials, including study setup, database design, and data cleaning.
Implement data management processes, including CRF design, data validation, query resolution, and database lock, ensuring accurate and timely data for analysis.
Ensure data integrity, adherence to GxP and ICH-GCP guidelines, and successful database lock for timely regulatory submissions.
Qualifications
Minimum of 7 years in clinical data management with at least 3-4 years of leadership experience, specifically in
Phase I and clinical pharmacology studies
Expertise with EDC systems (e.g., Medidata Rave), strong project management, and leadership skills. Familiarity with CDISC standards and regulatory submission processes.
Bachelor's degree in Life Sciences or related field. A Master's degree is a plus.'
