Director of Clinical Data Management
About The Position
The Director of Clinical Data Management will establish and lead the clinical data management function at Pathos. You will own clinical data collection, cleaning, and integrity across our oncology trials, ensuring our datasets are ready for analysis, regulatory submissions, and the next development decision. You will report to the Vice President, Head of Clinical Operations. This is the first CDM hire at Pathos. There is no existing playbook. You will write it. You will define how Pathos collects, cleans, and locks clinical data in a company built on small teams and AI agents, and you will set the standard for what audit ready trial data looks like in this operating model. The role sits at the intersection of clinical data discipline and an AI native operating model. You will spend less time chasing CRO status reports and more time on the data questions that move trials forward, because AI agents will absorb the routine query resolution, status tracking, discrepancy review, and document compilation work that traditionally consumed a CDM Director's calendar.
Requirements
- Bachelor's or Master's degree in Life Sciences, Data Management, or a related field.
- 10 or more years of progressive experience in clinical data management, including leadership of oncology trials.
- Deep working knowledge of EDC systems such as Medidata Rave, Veeva CDMS, or Oracle InForm, and clinical data standards including CDISC, SDTM, and ADaM.
- Demonstrated ability to manage CROs and vendors against quality, timeline, and budget commitments.
- Strong command of GCP, ICH, FDA, CDISC, GCDMP, 21 CFR Part 11, MedDRA, and WHO Drug Dictionaries, and how they apply in daily CDM practice.
Nice To Haves
- Experience operating in a flat, builder oriented organization where you specify, orchestrate, and ship rather than manage process.
- Experience gathering requirements and writing specifications for database integrations, including ePRO, central and local laboratory data uploads, supply management, IVRS, and IWRS.
- Experience building a CDM function from the ground up or substantially rebuilding one in a small company environment.
- Comfort orchestrating AI tools or agentic workflows in clinical data work, and clear instinct for where automation belongs and where human review must stay.
Responsibilities
- Own clinical data strategy and oversight
- Lead oversight of data management for outsourced clinical trials, including project planning, vendor coordination, internal review cycles, data cleaning, and approval of deliverables.
- Oversee CRO and vendor activities to ensure GCP compliance and execution against protocols and SOPs.
- Own consistency across trials and programs: CRF design and standards, Data Management Plans, CRF annotation and completion guidelines, edit check specifications, data entry and query status tracking, and database lock.
- Drive timely database lock, data quality, and readiness for statistical analysis and regulatory submissions.
- Direct AI agents to draft DMPs, edit check specs, and reconciliation reports, and apply your judgment to the final product.
- Manage CROs and vendors delivering CDM services, holding them to timelines, budgets, and quality standards.
- Develop and monitor Data Management Plans, Data Review Plans, and data transfer specifications.
- Resolve complex data issues, queries, and discrepancies in partnership with clinical and statistical teams.
- Use AI agents to compare vendor deliverables against specifications, surface drift early, and prepare structured feedback for vendor reviews.
- Serve as the primary CDM partner on every study team.
- Partner with Biostatistics, Clinical Operations, Medical Monitoring, and Data Science colleagues so that data supports trial endpoints and regulatory deliverables.
- Collaborate on the integration of clinical trial data with Pathos AI platforms and real world data sources so that operational data feeds back into model performance and decision support.
- Build and scale the CDM function as the company grows, including hiring and mentoring future staff.
- Develop SOPs, best practices, and quality frameworks that meet GCP, ICH, CDISC, and 21 CFR Part 11 expectations.
- Contribute to portfolio level planning and operational strategy, and translate CDM signals into actionable input for Clinical Operations leadership.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Associate degree
