Senior Clinical Study Lead

KPS Life; Uxbridge; Hybrid; GBP 90,000 - 120,000; Full time

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

Senior Clinical Study Lead (Sr. CSL) – Global Clinical Trials

KPS Life is seeking an experienced Senior Clinical Study Lead to drive the successful delivery of large and complex global clinical trials from protocol development through to study close-out.

In this role, you will lead cross-functional study teams and act as the primary point of contact for study oversight. You will be accountable for timelines, budget, quality, and ensuring full compliance with ICH/GCP and SOPs — whether studies are run internally or outsourced to CROs. Sponsor dedicated, 3 days in Uxbridge office is a must.

Key Responsibilities:

• Lead cross-functional teams and oversee end-to-end study execution
• Provide operational input into protocol development and key study documents (CRF, monitoring plan, SAP, etc.)
• 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; escalte issues with mitigation plans
• Ensure inspection readiness and support audits/CAPAs
• Oversee study close-out activities including database lock and TMF reconciliation

Requirements:

• Bachelor’s degree + minimum 8 years’ relevant clinical trial experience
• Proven experience leading global clinical trials and managing CROs/vendors
• Strong knowledge of ICH/GCP and regulatory requirements
• Demonstrated leadership, project management and cross-functional team collaboration skills
• Experience with CTMS, EDC, IWRS/IVRS and MS Project
• Excellent communication, negotiation and problem-solving abilities
• Up to 25% travel may be required

This is an excellent opportunity to play a key role in the operational delivery of high-impact clinical programs within a collaborative and forward-thinking environment.