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 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. #J-18808-Ljbffr
Senior Clinical Study Lead employer: kps life
KPS Life is an exceptional employer, offering a dynamic work environment in Oxford where innovation meets collaboration. As a Senior Clinical Trial Associate, you will benefit from a supportive culture that prioritises employee growth and development, alongside competitive remuneration and comprehensive benefits. Join us to be part of a team that values your contributions and fosters a sense of purpose in advancing clinical research.
