Lead Clinical Data Manager
Based in the United StatesFull-TimeLead
SalaryCompetitive compensation package based on experience, education, and location
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Job Details
- Experience
- 5–7+ years
- Required Skills
- GCP
Requirements
- 5–7+ years of clinical data management experience within pharmaceutical or biotechnology environments.
- Strong knowledge of clinical data standards including CDISC, SDTM, and CDASH.
- Knowledge of regulatory frameworks such as ICH and GCDMP.
- Hands-on experience with EDC systems and clinical data management tools, including data validation, reconciliation, and database lock processes.
- Familiarity with medical coding dictionaries such as MedDRA and WHO Drug.
- Experience supporting data review and cleaning activities.
- Strong project management and stakeholder coordination skills.
- Detail-oriented mindset with the ability to proactively identify and mitigate data quality risks.
Responsibilities
- Lead all clinical data management activities across studies from start-up through database lock and study close, ensuring high-quality and timely delivery of clinical data.
- Design and maintain clinical trial documentation including CRFs, data management plans, edit check specifications, data review plans, and data transfer agreements.
- Build and manage EDC systems, including study setup, UAT, data validation, and ongoing maintenance to ensure optimal data collection and flow.
- Oversee data cleaning, query management, discrepancy resolution, and reconciliation of clinical data across multiple sources.
- Ensure compliance with regulatory standards including GCP, CDISC (SDTM/CDASH), ICH guidelines, and 21 CFR Part 11 requirements.
- Collaborate with clinical operations, biostatistics, and other stakeholders to resolve data issues, generate reports, and support study decision-making.
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