Director, RWE/Epi, Inflammation & Immunology
Pfizer
Director of Clinical Data Management
PATHOS
full-time
Posted on:
Location Type: Hybrid
Location: New York City • New York • 🇺🇸 United States
Visit company websiteJob Level
Lead
Tech Stack
Google Cloud PlatformOracle
About the role
- Establish and lead the data management function at Pathos
- Own oversight of clinical data collection, cleaning, and integrity across oncology trials
- 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
- Drive adoption of modern, scalable data management tools and workflows
- Manage CROs and vendors delivering CDM services, ensuring compliance with timelines, budgets, and quality standards
- Serve as the primary CDM representative on cross-functional study teams
- 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
Requirements
- 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.
- 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 environment
Benefits
- Comprehensive health, dental, and vision insurance
- Flexible PTO and remote work options
- Professional development budget
- Opportunity to build something from scratch and have a massive impact
- Collaborative, innovative work environment
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical data managementdata cleaningdata integrityproject managementvendor managementEDC systemsdatabase systemsregulatory complianceGCP complianceclinical data standards
Soft skills
leadershipinterpersonal skillscollaborationmentoringproject oversightadaptabilitycommunicationteamworkproblem-solvinginitiative management
