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Regeneron

Manager, Global Study Start-Up

Regeneron

. Drive global execution of clinical-trial site activation .

Posted 11/3/2026full-timeUnited StatesMid-LevelSenior💰 $114,800 - $187,400 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in clinical trial site activation, including strategic planning, regulatory submissions, and cross-functional collaboration. Proficient in managing site start-up documentation and vendor relationships while ensuring compliance with ICH/GCP guidelines.

Highest-signal resume keywords
Clinical Trial Site ActivationRegulatory SubmissionsTrial Management SystemsVendor ManagementProject Management

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Site Start-Up StrategiesStudy Metrics AnalysisData-Driven Decision MakingSite SelectionDocument ManagementCRO Performance EvaluationMilestone TrackingSite Regulatory Packages PreparationCIRB SubmissionLIRB Submission
Soft Skills
Interpersonal SkillsLeadership SkillsEffective CommunicationNegotiation SkillsTime Management
Tools & Technologies
CTMSTMFMicrosoft ProjectMicrosoft PowerPointMicrosoft WordMicrosoft Excel
Industry Keywords
ICH GuidelinesGCP GuidelinesClinical Drug DevelopmentCross-Functional TeamsSite Intelligence

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Drive global execution of clinical-trial site activation
  • Develop site start-up strategies and identify dependencies, risks, and mitigation plans
  • Track and analyze study metrics to evaluate CRO performance and implement corrective actions
  • Guide cross-functional teams in data-driven site selection decisions
  • Develop, assess, and align site activation projections with cross-functional and CRO teams
  • Maintain complete and compliant site start-up documentation in the Trial Master File
  • Develop global country start-up strategies and monitor country intelligence
  • Support regulatory submissions, including site documentation, CIRB and LIRB submissions, and CRO insurance requests
  • Ensure timely country submission deliverables and clear critical-path ownership
  • Lead site start-up activities, including fast-track site initiation, site calls, document collection, and milestone tracking
  • Provide subject-matter expertise, training, and guidance on essential site documents, regulatory requirements, document management, and TMF filing
  • Oversee CRO site start-up management or the in-house regional SSU team
  • Collect and analyze site intelligence for site selection and start-up
  • Oversee preparation and approval of site regulatory packages
  • Represent Site Start-Up on cross-functional teams, provide updates, escalate challenges, and propose mitigation strategies
  • Resolve CRO and internal team SSU issues
  • Recommend and participate in cross-functional and departmental process improvements

Requirements

What you’ll need
  • Demonstrated interpersonal and leadership skills
  • Ability to understand and implement operational strategic direction and guidance for clinical studies
  • Data-driven approach to planning, execution, and problem solving
  • Effective verbal, written, and presentation communication skills
  • Proactive and self-disciplined, with ability to meet deadlines, manage time, and prioritize effectively
  • Ability to influence and negotiate across key stakeholders
  • Ability to build productive study team collaborations
  • Experience in the clinical drug development process, with expertise in study start-up
  • Demonstrated vendor management experience
  • Technical proficiency in trial management systems, including CTMS and TMF
  • Proficiency in Microsoft Project, PowerPoint, Word, and Excel
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Effective project management, cross-functional team interaction, and organizational skills
  • May require up to 25% travel

Benefits

Comp & perks
  • Annual bonuses or other incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Medical, dental, vision, life, and disability insurance benefits
  • Paid time off
  • Family support benefits
  • Reasonable accommodation during the recruitment process for applicants with known disabilities or chronic illnesses