Director, Clinical Data Management
Nuvation Bio
August 19, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Director of Clinical Data Management (CDM)
Responsibilities
- Serve as primary data management lead for assigned oncology clinical trials; ensure timely, high-quality deliverables.
- Develop and maintain study data management plans (DMPs), CRF completion guidelines, edit check specifications, and data transfer specifications.
- Oversee CRF design, eCRF programming, and database setup with CRO partners/internal stakeholders.
- Coordinate data review, query management, and data cleaning; support interim/final database lock.
- Ensure compliance with regulatory requirements (ICH GCP, FDA) and industry best practices (e.g., GCDMP).
- Integrate and reconcile external data sources (central labs, imaging, biomarkers, other third-party providers).
- Partner with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs; act as data management point-of-contact through planning, conduct, and closeout.
- Lead Data Working Groups and cross-functional data review meetings.
- Contribute to protocol and SAP development from a data management perspective.
- Provide oversight of ex-US DM collaborators, CROs, and vendors; participate in selection/contracting and define vendor performance metrics.
- Support SOP/process improvements; support audits/inspections; lead/participate in data-focused initiatives (e.g., new review tools, R Shiny apps, workflow standardization, ePRO/wearables).
- As team grows, may mentor/line-manage junior CDM staff/contractors and support onboarding/training.
Qualifications & Skills
- Bachelor’s degree required (life sciences, data science/statistics/math, computer science, health informatics, or related); advanced degree preferred.
- 8+ years clinical data management experience (biotech/pharma/CRO).
- 3+ years managing people, vendors, and functional teams.
- Leadership, strategic thinking, communication.
- Clinical data systems knowledge (preferably Medidata Rave) and CDISC standards (SDTM, CDASH).
- Vendor management/outsourced data management experience.
- Thorough understanding of GCP/ICH/regulatory guidelines.
- Fast-paced, hands-on mindset; startup/small biotech experience desirable.
- Oncology familiarity with complex data types (imaging, genomics, digital endpoints) desirable.
- Regulatory submission experience (NDA/BLA) is a plus.
Benefits
- Competitive base salary, bonus, and equity plans; unlimited vacation and 10 sick days annually; medical/dental/vision; 401(k) with matching.
No application instructions provided.
Responsibilities
- Serve as primary data management lead for assigned oncology clinical trials; ensure timely, high-quality deliverables.
- Develop and maintain study data management plans (DMPs), CRF completion guidelines, edit check specifications, and data transfer specifications.
- Oversee CRF design, eCRF programming, and database setup with CRO partners/internal stakeholders.
- Coordinate data review, query management, and data cleaning; support interim/final database lock.
- Ensure compliance with regulatory requirements (ICH GCP, FDA) and industry best practices (e.g., GCDMP).
- Integrate and reconcile external data sources (central labs, imaging, biomarkers, other third-party providers).
- Partner with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs; act as data management point-of-contact through planning, conduct, and closeout.
- Lead Data Working Groups and cross-functional data review meetings.
- Contribute to protocol and SAP development from a data management perspective.
- Provide oversight of ex-US DM collaborators, CROs, and vendors; participate in selection/contracting and define vendor performance metrics.
- Support SOP/process improvements; support audits/inspections; lead/participate in data-focused initiatives (e.g., new review tools, R Shiny apps, workflow standardization, ePRO/wearables).
- As team grows, may mentor/line-manage junior CDM staff/contractors and support onboarding/training.
Qualifications & Skills
- Bachelor’s degree required (life sciences, data science/statistics/math, computer science, health informatics, or related); advanced degree preferred.
- 8+ years clinical data management experience (biotech/pharma/CRO).
- 3+ years managing people, vendors, and functional teams.
- Leadership, strategic thinking, communication.
- Clinical data systems knowledge (preferably Medidata Rave) and CDISC standards (SDTM, CDASH).
- Vendor management/outsourced data management experience.
- Thorough understanding of GCP/ICH/regulatory guidelines.
- Fast-paced, hands-on mindset; startup/small biotech experience desirable.
- Oncology familiarity with complex data types (imaging, genomics, digital endpoints) desirable.
- Regulatory submission experience (NDA/BLA) is a plus.
Benefits
- Competitive base salary, bonus, and equity plans; unlimited vacation and 10 sick days annually; medical/dental/vision; 401(k) with matching.
No application instructions provided.