Associate Director, Clinical Data Management

Precigen; Germantown (MD); On-site; USD 150,000 - 190,000; Full time

Job summary

Precigen is seeking an Associate Director of Clinical Data to serve as the sponsor's data management lead on all company-sponsored studies. You will set standards, oversee CROs, and ensure data quality from design through lock, working with study leads and statisticians to enable analysis, submission, and publication.

You will drive data standards (CDASH, CDISC SDTM), oversee eCRF development and external data integration, and manage vendor performance across multiple programs in a fast-paced

Qualifications

• Bachelor's degree in life sciences, health informatics, computer science or related field.
• 10+ years in clinical data management, including sponsor-side vendor oversight.
• Hands-on experience with major EDC platforms (Medidata Rave, Veeva CDMS) and external data reconciliation.
• Working knowledge of CDISC (CDASH, SDTM), MedDRA/WHODrug coding, ICH E6(R3) and 21 CFR Part 11.
• Experience taking studies through database lock and supporting a regulatory submission; RWE or observational study experience valued.

Responsibilities

• Lead sponsor review and approval of data management plans, eCRF design, edit check specifications, data review plans and data transfer agreements.
• Oversee EDC build and participate in user acceptance testing; approve go-live.
• Monitor CRO data management performance against KPIs: query aging, data entry timeliness, open discrepancies and cleaning status.
• Own database lock readiness: lock checklists, reconciliation sign-off and sponsor approval to lock.
• Oversee integration and reconciliation of external data (central lab, IRT, eCOA/ePRO, imaging, biomarker) and SAE reconciliation with Safety.
• Oversee medical coding (MedDRA, WHODrug) with Clinical Science and Medical review.
• Partner with study leads and Clinical Science on ongoing clinical data review, listings and trend detection as part of risk-based quality management.
• Drive consistent data standards across the portfolio (CDASH collection, CDISC SDTM oversight) and reusable eCRF and edit-check libraries.
• Define data collection for Phase 3b/4, registry and chart review studies: abstraction forms, data dictionaries, source data quality checks and transfer specifications, proportionate to study risk.
• Ensure data management TMF artifacts are complete and current; support audits and inspections on data handling and computerized system validation.
• Contribute to vendor selection for CROs, EDC and specialty data vendors.
• Other duties as assigned.

Skills

Data management

Vendor oversight

Communication

Time management

Education

Bachelor's degree in life sciences

Tools

Medidata Rave

Veeva CDMS

Job description

Precigen is seeking an Associate Director of Clinical Data to serve as the sponsor's data management lead on all company-sponsored studies. You will set standards, oversee CROs, and ensure data quality from design through lock, working with study leads and statisticians to enable analysis, submission, and publication.

You will drive data standards (CDASH, CDISC SDTM), oversee eCRF development and external data integration, and manage vendor performance across multiple programs in a fast-paced