Clinical Start-Up Lead — Site Activation & Submissions

Roche; Burgess Hill; On-site; GBP 65,000 - 95,000; Full time

Job summary

Roche is seeking a Clinical Site Manager specialising in Study Start-Up to design, plan, coordinate, and conduct all activities involved in initiating and monitoring clinical research studies at assigned sites. You will drive site activation, manage regulatory submissions, and coordinate cross-functional teams to deliver compliant trials in a fast-paced environment.

You will lead end-to-end start-up efforts, ensure timely EC/CA approvals, and maintain high-quality documentation in line with GxP

Qualifications

• Degree in a scientific discipline or equivalent experience with clinical operations.
• Hands-on experience navigating EC and CA submissions.
• Strong knowledge of ICH-GCP and regulatory standards.

Responsibilities

• Lead end-to-end study start-up activities from site identification to activation.
• Manage EC and CA submissions and regulatory documentation on deadlines.
• Act as primary start-up expert for site personnel and coordinate certifications.
• Develop essential study documentation such as informed consent and patient guides.
• Collaborate with global and local teams to deliver clinical diagnostic solutions.
• Foster inclusive, cross-region teamwork and vendor coordination.

Skills

Clinical operations

Study start-up

Regulatory submissions

Stakeholder management

Cross-functional collaboration

Education

Science degree

Job description

Roche is seeking a Clinical Site Manager specialising in Study Start-Up to design, plan, coordinate, and conduct all activities involved in initiating and monitoring clinical research studies at assigned sites. You will drive site activation, manage regulatory submissions, and coordinate cross-functional teams to deliver compliant trials in a fast-paced environment.

You will lead end-to-end start-up efforts, ensure timely EC/CA approvals, and maintain high-quality documentation in line with GxP