Senior Global Clinical Study Lead — Cross‑Functional & CRO Oversight

KPS Life

Uxbridge

Hybrid

GBP 90,000 - 120,000

Full time

3 hours ago
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Job summary

KPS Life in the United Kingdom is seeking a Senior Clinical Study Lead to drive the delivery of large, global clinical trials from protocol development through study close-out. You will lead cross-functional study teams and act as the primary contact for study oversight, accountable for timelines, budget, quality, and ensuring ICH/GCP compliance, whether studies are run in-house or outsourced to CROs.

This sponsor-dedicated role requires 3 days in the Uxbridge office, with up to 25% travel.

Qualifications

  • Bachelor’s degree and 8+ years in clinical trials; global study leadership.
  • Proven experience managing CROs/vendors and regulatory compliance.
  • Strong project management and cross-functional collaboration.
  • Experience with CTMS, EDC, IWRS/IVRS, and MS Project.

Responsibilities

  • Lead cross-functional teams and oversee end-to-end study execution.
  • Provide input into protocol development and key study documents (CRF, monitoring plan, SAP).
  • Manage study systems (CTMS, TMF) and ensure registry compliance.
  • Lead vendor selection, contracting and oversight.
  • Drive site selection, activation, recruitment & retention strategies.
  • Monitor data quality, timelines and budget; escalate issues with mitigation plans.
  • Ensure inspection readiness and support audits/CAPAs.
  • Oversee study close-out activities including database lock and TMF reconciliation.

Skills

Cross-functional leadership
Study management
Regulatory knowledge
CTMS/EDC/IWRS
MS Project
Budget management
Communication
Travel readiness

Education

Bachelor’s degree

Tools

CTMS
EDC
IWRS/IVRS
MS Project

Job description

KPS Life in the United Kingdom is seeking a Senior Clinical Study Lead to drive the delivery of large, global clinical trials from protocol development through study close-out. You will lead cross-functional study teams and act as the primary contact for study oversight, accountable for timelines, budget, quality, and ensuring ICH/GCP compliance, whether studies are run in-house or outsourced to CROs.

This sponsor-dedicated role requires 3 days in the Uxbridge office, with up to 25% travel.

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