Impactful Clinical Trials Start-Up Lead in UK

Roche; Welwyn; On-site; GBP 90,000 - 120,000; Full time

Job summary

Roche in Welwyn, United Kingdom, is seeking a UK Country Study Start-Up Team Leader (cSTL) to drive efficient initiation of Roche-sponsored clinical trials onsite in the UK. You will lead start-up strategy, collaborate with regional and global teams, and ensure regulatory compliance while building a high-performance, inclusive team.

The role demands strong knowledge of ICH-GCP, MHRA CTA, and UK regulations, with extensive experience in trial start-up, submissions, site activation, and budget

Qualifications

• Experience in clinical trial start-up, regulatory submissions, and site activation.
• Proven leadership with coaching and team development.
• Excellent communication and interpersonal skills.
• Fluency in English (written and spoken).

Responsibilities

• Oversee start-up operations for site activation and regulatory compliance.
• Lead Country Leadership Team and provide strategic insights.
• Collaborate with regional/global teams to standardise systems and timelines.
• Oversee submissions, amendments, and document management.
• Identify automation and process improvement opportunities.
• Manage budgeting and contract negotiation.
• Engage with ethics boards and health authorities on policies.
• Foster inclusive, high-performance culture and talent development.
• Handle Workday-related administration and other HR matters.
• Provide coaching and leadership to direct reports.

Skills

Leadership

Regulatory submissions

Clinical start-up

Cross-functional

Veeva Vault

CTIS

RIM

ICH-GCP

MHRA CTA

English fluency

Education

Life sciences degree

Postgraduate degree

Tools

Veeva Vault

CTIS

RIM

Job description

Roche in Welwyn, United Kingdom, is seeking a UK Country Study Start-Up Team Leader (cSTL) to drive efficient initiation of Roche-sponsored clinical trials onsite in the UK. You will lead start-up strategy, collaborate with regional and global teams, and ensure regulatory compliance while building a high-performance, inclusive team.

The role demands strong knowledge of ICH-GCP, MHRA CTA, and UK regulations, with extensive experience in trial start-up, submissions, site activation, and budget