kps life
Senior Clinical Study Lead
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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; escalate issues with mitigation plans
- Ensure inspection readiness and support audits/CAPAs
- Oversee study close-out activities including database lock and TMF reconciliation
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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
- Budget management experience required
- Up to 25% travel may be required
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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.
Interested? Send your CV to mmirowska@kpslife.com
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