About the RoleThe
Director of Clinical Data Management (CDM) will establish and lead the data management function at Pathos. This role reports to the Chief Clinical Operations Officer and is ideal for a hands-on data leader who thrives in high-growth, fast-moving environments and is excited to build CDM strategy, systems, and processes from the ground up.
You will own oversight of clinical data collection, cleaning, and integrity across our oncology trials, ensuring datasets are of the highest quality for analysis, regulatory submissions, and decision-making.
Key ResponsibilitiesClinical Data Strategy & Oversight- Leads oversight of data management for outsourced clinical trials including project management, vendor management, coordination of internal reviews and data cleaning process, and approval of deliverables.
- Oversees CRO/Vendor activities to ensure GCP compliance, ensure all work is carried out in strict accordance with the relevant protocols, Standard Operating Procedures, and in compliance with Good Clinical Practices.
- Oversees data management activities to maintain consistency across trials/development projects: including Case Report Form (CRF) design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check programs/specifications, data entry and query status tracking, and database closure.
- Ensure timely database lock, data quality, and readiness for statistical analysis and regulatory submissions.
- Drive adoption of modern, scalable data management tools and workflows.
Execution & Vendor Management- Manage CROs and vendors delivering CDM services, ensuring compliance with timelines, budgets, and quality standards.
- Develop and monitor CDM plans, including Data Management Plans (DMPs), Data Review Plans (DRPs), and data transfer specifications.
- Resolve complex data issues, queries, and discrepancies in collaboration with clinical and statistical teams.
Cross-Functional Collaboration- Serve as the primary CDM representative on cross-functional study teams.
- Partner with Biostatistics, Clinical Operations, Clinical Development, and Data Science colleagues to ensure data supports trial endpoints and regulatory deliverables.
- Collaborate on integration of clinical trial data with Pathos' AI/ML platforms and real-world data sources.
Leadership & Compliance- Build and scale the CDM function, including hiring and mentoring staff.
- Develop SOPs, best practices, and quality frameworks to ensure compliance with GCP, ICH, and regulatory requirements.
- Contribute to portfolio-level planning and operational strategy.
What We're Looking For- Bachelor's or Master's degree in Life Sciences, Data Management, or related field.
- 10+ years of progressive experience in clinical data management, including leadership in oncology trials.
- Deep knowledge of EDC systems (e.g., Medidata Rave, Veeva CDMS, Oracle InForm) and clinical data standards (CDISC, SDTM, ADaM).
- Experience in gathering requirements and preparation of specifications for database systems and integrations e.g. ePRO, laboratory data uploads, supply management, IVRS, IWRS, etc. would be highly regarded.
- Knowledge of regulatory and industry standards (e.g. ICH/FDA guidelines, GCP, CDISC standards, GCDMP, 21 CFR 11, MedDRA and WHO Drug dictionaries etc.) and their application to Data Management practice. Prior experience filing a NDA/MAA/BLA preferred
- Experience managing CROs/vendors and building CDM functions preferred
- Proven ability to manage multiple initiatives and shifting priorities within a small company environment; excellent interpersonal skills with the ability to work independently and collaboratively in a dynamic team
LocationThis is a hybrid role, requiring 3 days per week onsite, in our NYC Headquarters.
The pay range for this role is:
200,000 - 240,000 USD per year (New York Office - ACLS East Tower)
