Senior Manager, Clinical Data

Precigen, Inc; Germantown (MD); On-site; USD 150,000 - 165,000; Full time

Job summary

Precigen, Inc. in Germantown, MD, seeks a Senior Manager, Clinical Data to lead sponsor data management for company-sponsored studies, setting standards and overseeing vendor delivery from design to lock.

You will ensure data quality and work with study leads and the Biostatistician for analyses and publications. Responsibilities include leading data management plans, EDC build, KPI monitoring of CROs, database lock readiness, data integration, and MedDRA/WHODrug coding.

Qualifications

• Bachelor's degree in life sciences, health informatics, computer science or related field.
• 7+ years in clinical data management.
• 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.

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.

Skills

Clinical data management

Data quality oversight

Regulatory submissions support

Vendor management

Cross-functional collaboration

Education

Bachelor's degree in life sciences, health informatics, computer science or related field

Tools

Medidata Rave

Veeva CDMS

CDISC (CDASH/SDTM)

WHODrug/MedDRA coding

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Manager, Clinical Data

Regulatory and Clinical Full-time Regular Germantown, MD, US

Salary Range: $150,000.00 To $165,000.00 Annually

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 Senior Manager, 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.
• 7+ years in clinical data management
• 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.