Note: The job is a remote job and is open to candidates in USA. Nuvation Bio is a biopharmaceutical company developing novel therapeutic candidates to address unmet needs in oncology. The Director of Clinical Data Management will lead study-level data management activities for oncology clinical development programs, overseeing data planning, execution, quality, regulatory compliance, cross-functional collaboration, and vendor deliverables. The role may also include mentoring or line management responsibilities as the organization grows.
Responsibilities
- Serve as the primary data management lead for assigned clinical trials, ensuring timely, high-quality data deliverables throughout the data lifecycle
- Develop and maintain study-specific data management plans (DMPs) and associated documents such as CRF completion guidelines, edit check specifications, and data transfer specifications
- Oversee case report form (CRF) design, eCRF programming, and database setup activities in coordination with CRO partners and internal stakeholders
- Coordinate and perform data review, query management, and data cleaning activities; support interim and final database lock processes
- Ensure that data management practices are consistent with applicable regulatory requirements (e.g., ICH GCP, FDA) and industry best practices (e.g. GCDMP)
- Support the integration and reconciliation of external data sources, including central labs, imaging, biomarker, and other third-party data providers
- Work closely with Clinical Operations, Biostatistics, Medical, and Regulatory Affairs to align trial objectives, timelines, and data expectations
- Act as the data management point-of-contact during study planning, conduct, and closeout phases
- Lead Data Working Groups and cross-functional data review meetings to ensure data quality is maintained throughout the study
- Contribute to the development of clinical trial protocols and statistical analysis plans (SAPs) from a data management perspective
- Collaborate with and provide oversight of NUVB ex-US DM collaborators, CROs and third-party vendors, ensuring the quality and timeliness of deliverables
- Participate in vendor selection and contracting activities; contribute to the development of vendor performance metrics
- Ensure effective communication between vendors and internal teams to proactively address data-related issues
- Contribute to the development and continuous improvement of data management processes, SOPs, and standards within the organization
- Support regulatory inspections and audits by providing documentation and subject matter expertise as needed
- May lead or participate in data-focused initiatives, such as implementing new data review tools and R shiny apps, standardizing data review workflows, or adopting novel data sources (e.g., ePRO, wearables)
- As the team grows, may provide mentorship or line management to junior CDM staff or contractors
- Participate in training, onboarding, and professional development of new team members
Skills
- Bachelor's degree in life sciences, data science/statistics/math, computer science, health informatics, or related field required
- 8+ years of clinical data management experience in the biotech, pharmaceutical, or CRO industry
- 3+ years of experience managing people, vendors, and functional teams
- Strong leadership, strategic thinking, and communication skills
- Strong working knowledge of clinical data systems (preferably Medidata Rave) and CDISC standards (SDTM, CDASH)
- Experience managing third-party vendors and overseeing outsourced data management activities
- Thorough understanding of GCP, ICH, and relevant regulatory guidelines
- Comfortable working in a fast-paced, hands-on environment with the ability to pivot as priorities evolve
- Demonstrated ability to balance strategic thinking with hands-on execution
- Advanced degree preferred
- Prior experience working in a small biotech or startup environment is highly desirable
- Familiarity with complex data types (e.g., imaging, genomics, digital endpoints) in oncology trials is desirable
- Experience supporting regulatory submissions (e.g., NDA, BLA) is a plus
Benefits
- Competitive Base Salary, Bonus, and Equity Plans
- Unlimited Vacation and 10 Sick Days Annually
- Excellent Medical, Dental, and Vision Coverage
- 401K with Company Matching
- Annual performance-based bonus
- Long-term incentive units (equity) provided as part of the compensation package
- A full range of medical, financial, and/or other benefits, depending on the level and position offered
Company Overview
Company H1B Sponsorship