Associate Director Clinical Data Management Contractor

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.'