Clinical Study Lead - Inflammation & Immunology (Hybrid)

Regeneron Pharmaceuticals, Inc

Cambourne

Hybrid

GBP 112,000 - 146,000

Full time

9 days ago

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Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Senior Clinical Study Lead to join the Clinical Trial Management team. You will globally manage large, complex trials from design to closeout, leading cross-functional study teams, overseeing CROs, and ensuring timeliness, budget adherence, and compliance with ICH/GCP and Regeneron SOPs.

Location options include on-site with hybrid flexibility; travel up to 25%. You will supervise staff, drive process improvements, and contribute to clinical study

Qualifications

  • Bachelor's degree and 8+ years of relevant clinical trial experience.
  • Extensive global clinical trial operations experience with ICH/GCP knowledge.
  • Line management experience and ability to build, lead, and develop productive study teams.
  • Strong budget management, vendor management, and negotiation skills.

Responsibilities

  • Lead cross-functional study teams with accountability for timelines, budget, and quality.
  • Provide operational input into protocol development and key study documents (data management, monitoring,.SAP).
  • Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment strategies.
  • Select, contract, and oversee CROs and vendors to ensure delivery against scope of work.
  • Manage study budgets and timelines, identify risks, and escalate issues with mitigation plans.
  • Oversee data quality, protocol deviations, and study systems (CTMS, TMF) to ensure audit readiness.
  • Supervise and develop Clinical Trial Management staff while driving process improvement.

Skills

Cross-functional leadership
Budget management
Vendor management
Communication skills
Team leadership

Education

Bachelor's degree

Tools

CTMS
EDC
IVRS/IWRS
MS Office

Job description

Regeneron Pharmaceuticals, Inc. is seeking a Senior Clinical Study Lead to join the Clinical Trial Management team. You will globally manage large, complex trials from design to closeout, leading cross-functional study teams, overseeing CROs, and ensuring timeliness, budget adherence, and compliance with ICH/GCP and Regeneron SOPs.

Location options include on-site with hybrid flexibility; travel up to 25%. You will supervise staff, drive process improvements, and contribute to clinical study

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