Study Start-Up Lead (SSUL)

F. Hoffmann-La Roche AG

United Kingdom

Remote

GBP 70,000 - 95,000

Full time

4 days ago
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Job summary

Roche Welwyn office in the United Kingdom is seeking a UK Study Start-Up Lead to drive efficient trial initiation and regulatory submissions across therapeutic areas. You will work with local and global teams, CROs, site staff to accelerate start-up while ensuring compliance.

The ideal candidate has proven experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration, with excellent communication, strong organizational and analytical skills, and fluency in

Qualifications

  • Experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
  • Strong understanding of UK regulatory environments and REC/MHRA/HRA submission processes.
  • Site budgeting and contracting development experience.

Responsibilities

  • Lead the country's study start-up strategy with focus on efficiency and collaboration with external stakeholders.
  • Oversee start-up operations ensuring timely site activation and regulatory compliance.
  • Engage with government and institutional bodies (Ethics Boards, Health Authorities) to align on policies and practices.
  • Provide strategic planning and oversight for budgeting and contract management.
  • Identify opportunities for process automation, standardisation, and innovation.

Skills

Regulatory submissions
Cross-functional collaboration
Excellent communication
Interpersonal skills
Organisational skills
Analytical skills
Problem-solving
English fluency

Education

MD/PhD/MA/MS/BA/BS in life sciences or equivalent
Postgraduate or master's degree desirable

Job description

## Study Start-Up Lead (SSUL)Apply: Welwyn: Full time: Posted Today: End Date: October 1, 2026 (12 days left to apply): 202609-123876At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.### ### The PositionAs a UK Study Start-Up Lead, you will drive and facilitate efficient study start-up processes to help us deliver clinical trials to patients. You'll enable innovative clinical trial delivery, address study start-up needs across various therapeutic areas, and ensure seamless trial execution for patients, investigators, and clinical site staff in the UK. Collaboration with local and global teams, as well as CROs, is essential to this role.****The Opportunity****In this role, you will be responsible for the efficient and compliant initiation of Roche-sponsored clinical trials. This includes developing and implementing effective start-up strategies, overseeing start-up operations, and driving process improvements at the country and site level while maintaining regulatory compliance. This role is internally known as the Study Start-Up Lead (SSUL).****Your key responsibilities will include:***** Leading the country's study start-up strategy, focusing on efficiency, innovation, and collaboration with external stakeholders.* Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.* Engaging with government and institutional bodies, such as Ethics Boards and Health Authorities, to align on clinical trial policies and practices.* Providing comprehensive strategic planning and oversight for budgeting and contract management.* Identifying and driving opportunities for process automation, standardisation, and innovation.* You will champion inclusive behaviours in your team and provide opportunities for their growth and development.****Who you are****You are a professional with demonstrated experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration. You have a strong understanding of the UK research and regulatory environments, including REC/MHRA/HRA submission processes and site budget and contracting development.****The ideal candidate will also have:***** A degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent, with a postgraduate or master's degree being highly desirable.* Excellent communication and interpersonal skills.* Strong organisational, analytical, and problem-solving capabilities.* Fluency in both written and spoken English****We have multiple headcounts available for this role.*******This role is based onsite at our Welwyn, United Kingdom office.******Relocation benefits are not available for this job posting.***We look forward to your application.
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