Associate Director, Clinical Data Management
New
C
Character BiosciencesPrecision Medicine
Source API remote eligibility restrictions: United StatesFull-TimeManager
Salary$179,000-$210,000 / year
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Job Details
- Experience
- 5–7+ years of Clinical Data Management experience
- Required Skills
- GCP
Requirements
- Bachelor’s degree required; Master’s degree preferred.
- Typically 5–7+ years of Clinical Data Management experience across multiple trial phases.
- Hands-on experience with EDC platforms (e.g., Medidata Rave, Veeva Vault CDMS).
- Strong understanding of data cleaning processes, including query management, external data reconciliation, and medical coding (MedDRA/WHODrug).
- Experience independently managing external Data Management vendors and CROs.
- Working knowledge of GCP, 21 CFR Part 11, and clinical data standards (e.g., CDISC/CDASH).
- Proven ability to build processes and systems from the ground up.
- High integrity and comfort operating independently.
Responsibilities
- Lead the development of data management processes and execution across clinical trials.
- Manage external Data Management vendors and CROs, holding them accountable for deliverables and quality.
- Oversee the development of Data Management Plans, defining data flow, roles, and quality standards.
- Partner with cross-functional stakeholders to align data collection with study design.
- Lead eCRF and database design, build, and testing (UAT) in the EDC system.
- Drive data cleaning activities, including query management, external data reconciliation, and medical coding.
- Lead database lock activities and ensure compliance with GCP and 21 CFR Part 11.
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