Study Start-Up Lead (SSUL)

Roche; United Kingdom; On-site; GBP 90,000 - 130,000; Full time

Job summary

Roche in the United Kingdom seeks a Study Start-Up Lead to drive efficient start-up processes for Roche-sponsored clinical trials. You will coordinate with local and global teams, CROs and investigators to ensure timely site activation and regulatory compliance across therapies, while shaping strategy and budgeting at country level.

The role requires strong experience in clinical trial start-up, regulatory submissions and broad stakeholder engagement, including REC/MHRA/HRA processes, with a

Qualifications

• Experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Strong knowledge of the UK research and regulatory environments (REC/MHRA/HRA submissions).
• Advanced degree in life sciences; postgraduate degree highly desirable.

Responsibilities

• Lead country study start-up strategy focusing on efficiency, innovation and external collaboration.
• Oversee start-up operations, site activations and regulatory compliance.
• Engage with government bodies and authorities to align on policies and practices.
• Provide strategic planning and oversight for budgeting and contract management.
• Identify and drive opportunities for automation, standardisation and innovation.
• Champion inclusive behaviours and development within the team.

Skills

English fluency

Communication

Analytical thinking

Organisational skills

Education

MD/PhD or equivalent degree

Job description

As 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.

  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., 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

  A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

  Let's build a healthier future, together. The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants' requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.