Lead Clinical Site Manager – Study Start Up, In Vitro Diagnostic Regulation

Roche

Lead Clinical Site Manager specializing in IVDR and Study Start-Up at Roche. Collaborating on initiating and managing clinical research studies for enhanced healthcare outcomes.

Posted 5/24/2026full-timeBurgess Hill • 🇬🇧 United KingdomSeniorWebsite

About the role

Key responsibilities & impact

Lead end-to-end study start-up activities
Manage Ethics Committee (EC) and Competent Authority (CA) submissions
Provide robust CRO oversight
Act as the primary contact and clinical trial expert
Develop critical study documentation

Requirements

What you’ll need

A degree in a scientific discipline or related field
Direct experience in Clinical Operations
Demonstrated experience in CRO oversight
Strong understanding of In Vitro Diagnostic Regulation (IVDR)
Exceptional verbal and written communication skills (English)

Benefits

Comp & perks

encourage personal expression
open dialogue
genuine connections
access to healthcare

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical operationsCRO oversightstudy documentationstudy start-up activitiesEthics Committee submissionsCompetent Authority submissions

Soft Skills

verbal communicationwritten communication