Associate Director, Clinical Data

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(Nasdaq: PGEN) is a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to address difficult-to-treat diseases with high unmet patient need.Precigenis dedicated to advancing scientific breakthroughs from proof-of-concept through commercialization. With a strong commitment to innovation, Precigen is developing a robust pipeline of differentiated therapies utilizing the company’s AdenoVerse® and UltraCAR-T® therapeutic platforms across its core focus areas of immuno-oncology, autoimmune disorders, and infectious diseases.

POSITION SUMMARY:

The Associate Director, Clinical Data is the sponsor's data management lead for every company-sponsored study, across Clinical Development and Medical Affairs. Data management is outsourced to CROs and specialty vendors; this role sets standards, oversees vendor delivery and owns sponsor accountability for data quality from database design through lock. The role works hand in hand with study leads and the Biostatistician so data are fit for analysis, submission and publication.

DUTIES AND 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.

EDUCATION AND EXPERIENCE:

• 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 (e.g. 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.

DESIRED KEY COMPETENCIES:

• Self-organizer, highly motivated, and keen attention to detail.
• Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
• Ability to understand and execute the company’s mission and values.
• Maintain a high degree of ethical standard and trustworthiness.
• Exhibits an open mindset when approaching challenges and conflict.
• Ability to think and adapt to a rapidly changing environment and demands.
• Strong time management and organizational skills.
• Ability to manage multiple projects in a fast-paced environment.