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Associate Director Clinical Data Management

Meet
South San Francisco, CA Temporary
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/2/2025

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.
  • Technical Data Management Execution : Implement data management processes, including CRF design, data validation, query resolution, and database lock, ensuring accurate and timely data for analysis.
  • Quality Assurance & Regulatory Compliance : Ensure data integrity, adherence to GxP and ICH-GCP guidelines, and successful database lock for timely regulatory submissions.

Qualifications :

  • Experience : 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 .
  • Skills : Expertise with EDC systems (e.g., Medidata Rave), strong project management, and leadership skills. Familiarity with CDISC standards and regulatory submission processes.
  • Education : Bachelor's degree in Life Sciences or related field. A Master's degree is a plus.'
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