Associate Director Clinical Data Management Contract

Job TitleAssociate Director, Clinical Data Management (Contractor)LocationHybrid (South San Francisco, CA)Duration6 Months ContractCompanyMid-Size Biotechnology CompanyJob OverviewWe 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 ResponsibilitiesLead Data Management for Phase I & Clinical Pharmacology StudiesOversee clinical trial data management activities for early-phase trials, including study setup, database design, and data cleaning.Technical Data Management ExecutionImplement data management processes, including CRF design, data validation, query resolution, and database lock, ensuring accurate and timely data for analysis.Quality Assurance & Regulatory ComplianceEnsure data integrity, adherence to GxP and ICH-GCP guidelines, and successful database lock for timely regulatory submissions.QualificationsExperienceMinimum of 7 years in clinical data management with at least 3-4 years of leadership experience, specifically in Phase I and clinical pharmacology studiesSkillsExpertise with EDC systems (e.g., Medidata Rave), strong project management, and leadership skills. Familiarity with CDISC standards and regulatory submission processes.EducationBachelor's degree in Life Sciences or related field. A Master's degree is a plus.'

Created: 2025-02-01