New · posted Nov 11
Precigen · Biotechnology
Senior Manager, Clinical Data
- Germantown, MD
- On-site
- Full-time
- Manager
The role
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.
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. Precigen is 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.
What you need
- 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.
Where you'll work
Germantown, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Germantown, MDJob intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $150,000 | $164,000 | $181,000 |
Comparisons: the base pay employers published on open Clinical Data Management roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Data Management
The general path across 65 open Clinical Data Management roles on Regulatory Jobs, with the titles they carry most. Not Precigen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 29 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Data and digital systems8
- Clinical trial conduct8
- Collaboration and leadership4
- GMP and compliance2
- Documentation and SOPs2
- Regulatory submissions2
- Lab testing and methods1
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Data Management work in biotechnology, led by the four this posting names, each linked to the agency or standards body that publishes it.
- CDISCCDISC standards(official source, opens in a new tab)SDTM, ADaM and CDASH, the clinical data standards FDA and PMDA requireNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signaturesNamed in the posting
- ICHMedDRA(official source, opens in a new tab)The ICH medical terminology for coding adverse events and medical historyNamed in the posting
- FDAFDA study data standards(official source, opens in a new tab)Required data standards and technical conformance for clinical study data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- ICHICH E3(official source, opens in a new tab)Structure and content of clinical study reports
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Precigen on Regulatory Jobs
- 8
- Open roles
- 8
- Distinct roles
- 1
- Locations
By discipline
- Clinical5 63%
- Regulatory2 25%
- Quality1 13%
By level
- Manager6 75%
- Director1 13%
- Senior & Principal1 13%
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Senior Manager, Clinical Data at Precigen
Open until filled.