Associate Director, External Clinical Data Management
Regeneron
full-time
Posted on:
Location Type: Office
Location: Warren • New York • 🇺🇸 United States
Visit company websiteSalary
💰 $154,800 - $252,800 per year
Job Level
Senior
About the role
- Shape and implement the strategy for External Data Services
- Lead and manage a team of External Data Services Managers and Specialists
- Oversee the development and maintenance of all DTS documents, ensuring alignment with Regeneron standards, processes, and timelines
- Drive the External Data Vendor Oversight model, establishing effective communication, partnership-level processes, and portfolio-level transparency on DTS status and escalations
- Represent External Data Services in leadership forums and technology discussions
- Contribute to and execute the External Data Services technology strategy
- Provide expert-level guidance to CROs, stakeholders, and external vendors on External Data Services
- Identify process gaps and lead initiatives to improve processes
- Track milestones and deliverables, escalate issues, and communicate portfolio-level updates to stakeholders
- Lead or contribute to special projects requiring strategic input and expertise in External Data
- Serve as a subject matter expert (SME) for complex topics requiring leadership-level commitment
- Develop SOPs, Work Instructions, Guidance Manuals, and other DTS development tools
- Provide coaching, mentoring, and performance management for direct reports
- Manage resource allocation and planning for External Data Services
Requirements
- A minimum of 10+ years of experience in External Clinical Data Management
- At least 4 years of people management experience
- A Bachelor’s degree in Science, Health, Computing, or a related field
- Hands-on experience with Imaging Data is required
- Advanced knowledge of Biomarker data types and/or Imaging Data for oncology and non-oncology studies is a plus
- Expert knowledge of database structures is preferred
Benefits
- health and wellness programs
- fitness centers
- equity awards
- annual bonuses
- paid time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
External Clinical Data ManagementImaging DataBiomarker data typesDatabase structuresDTS document developmentSOP developmentWork InstructionsGuidance ManualsResource allocationPerformance management
Soft skills
LeadershipTeam managementCommunicationCoachingMentoringStrategic inputProcess improvementStakeholder engagementProblem-solvingExpert guidance
Certifications
Bachelor’s degree in ScienceBachelor’s degree in HealthBachelor’s degree in Computing