Senior Manager, Clinical Data: Data Quality & Submissions

Precigen; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Precigen, a leading biopharmaceutical company, is seeking a Senior Manager, Clinical Data to serve as the sponsor's data management lead for company-sponsored studies. You will set standards, oversee vendor delivery, and ensure data quality from database design through lock, collaborating with study leads and Biostatistics to ensure data are fit for analysis and submission.

You will manage data collection for trials, oversee external data reconciliation, regulatory submissions support, and drive

Qualifications

• 7+ years in clinical data management.
• 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 regulatory submissions.

Responsibilities

• Lead sponsor review and approval of data management plans and related specifications.
• Oversee EDC build and participate in user acceptance testing; approve go-live.
• Monitor data management KPIs: query aging, data entry timeliness, open discrepancies and cleaning status.
• Own database lock readiness and sponsor sign-off to lock.
• Oversee data integration from external sources (lab, IRT, eCOA/ePRO, imaging, biomarkers).
• Oversee medical coding (MedDRA, WHODrug) with Clinical Science and Medical Review.
• Partner with study leads on data review, listings and trend detection as part of risk-based quality management.
• Drive CDASH/CDISC standards and reusable eCRF/edit-check libraries.

Skills

Clinical Data Management

Project Coordination

Communication

Education

Bachelor's degree in life sciences or related field

Tools

Medidata Rave

Veeva CDMS

CDISC SDTM

MedDRA/WHODrug

Job description

Precigen, a leading biopharmaceutical company, is seeking a Senior Manager, Clinical Data to serve as the sponsor's data management lead for company-sponsored studies. You will set standards, oversee vendor delivery, and ensure data quality from database design through lock, collaborating with study leads and Biostatistics to ensure data are fit for analysis and submission.

You will manage data collection for trials, oversee external data reconciliation, regulatory submissions support, and drive