Study Start-Up Lead

Roche; Welwyn; On-site; GBP 70,000 - 100,000; Full time

Job summary

Roche in the United Kingdom is seeking a UK Study Start-Up Lead to drive efficient start-up processes for Roche-sponsored clinical trials. You will coordinate across therapeutic areas, CROs, and internal teams to enable timely site activation and regulatory compliance.

The role requires strong experience in trial start-up and UK regulatory submissions, with a focus on budgeting and process improvements. This onsite position in Welwyn emphasizes collaboration and innovative trial delivery.

Qualifications

• Experience in clinical trial start-up and regulatory submissions.
• Knowledge of UK REC/MHRA/HRA submission processes.
• Strong budgeting and cross-functional collaboration skills.

Responsibilities

• Lead the UK's study start-up strategy focusing on efficiency and collaboration with external stakeholders.
• Oversee start-up operations, site activation, and regulatory compliance.
• Engage with Ethics Boards and Health Authorities to align on policies and practices.
• Provide strategic planning and oversight for budgeting and contracts.
• Identify opportunities for process automation, standardisation, and innovation.
• Champion inclusive behaviours and support team development.

Skills

Clinical trial start-up

Regulatory submissions

Cross-functional collaboration

English fluency

Budgeting

Education

MD/PhD or life sciences degree

Tools

Regulatory submission tools

Budgeting tools

Job description

Description

At 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 Position

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.

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.

Who we are

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.