Country Study Start-Up Team Leader (cSTL)

Roche; Welwyn; On-site; GBP 85,000 - 125,000; Full time

Benefits offered by this job

Health insurance

Pension scheme

Job summary

Roche UK is seeking a UK Country Study Start-Up Team Leader to drive efficient initiation of Roche-sponsored clinical trials in the UK, ensuring regulatory compliance and timely site activation. You will lead start-up operations, submissions, budgeting, and contracting, while building strong partnerships with regional and global teams.

The role requires leadership, strong communication, and deep knowledge of ICH-GCP and MHRA processes.

Qualifications

• Experience in clinical trial start-up, regulatory submissions, and cross-functional collaboration.
• Strong knowledge of ICH-GCP, MHRA CTA, and the UK regulatory environment.
• Degree in life sciences; postgraduate degree desirable.
• Proven leadership and people-management experience.
• Excellent communication, organizational, and analytical skills.

Responsibilities

• Overseeing start-up operations for site activation and regulatory compliance.
• Lead submissions, amendments, and document maintenance.
• Engage with government and authorities to shape trial policies.
• Coach and develop a team, fostering inclusion and growth.

Skills

Clinical trial start-up

Regulatory submissions

Leadership

Cross-functional collaboration

Budgeting & contracts

Communication skills

Problem solving

Education

Life sciences degree (MD/PhD/MA/MS/BA/BS)

Postgraduate degree desirable

Tools

Veeva Vault

CTIS

RIM

Job description

As a UK Country Study Start-Up Team Leader, you will drive the efficient and compliant initiation of Roche-sponsored clinical trials. You will play a key role in delivering clinical trials to patients by enabling innovative trial execution and ensuring a seamless experience for investigators and clinical site staff in the UK.

The Opportunity

• Overseeing start-up operations to ensure timely and efficient site activation and regulatory compliance.
• Serve as a key member of the Country Leadership Team, contributing actionable insights and leadership influence to advance clinical study start-up environments.
• Build and maintain collaborative relationships with regional and global counterparts to standardise systems, improve study timelines, and implement innovations across study processes.
• Leading the development and oversight of clinical trial submissions and amendments, managing packages, and ensuring document maintenance.
• Identifying and driving opportunities for process automation, standardisation, and innovation at the country and site level.
• Providing strategic oversight for all aspects of budgeting and contract management, including developing budget strategies and negotiating contracts.
• Engaging with government and institutional bodies, such as Ethics Boards and Health Authorities, to align on and influence evolving clinical trial policies and practices.
• Driving department-wide engagement by fostering a culture of collaboration, inclusivity, and high performance while championing inclusion and belonging. Inspire, motivate, and develop talent within the team, ensuring a focus on individual growth and leadership development to build a strong, elevated talent pipeline aligned with organisational objectives.
• Leading by example in demonstrating and championing inclusive behaviours in your team, PDG, PD, and the Roche Enterprise. Provide opportunities for growth and development for all team members and address any barriers that may exist.
• People management-related administration (e.g. Workday People & Culture Management system tasks) and contact for employment-related matters.
• You will also provide coaching, support, and leadership to a team of direct reports. You will champion inclusive behaviours and provide opportunities for growth and development for all team members.

Who you are

• You are an experienced professional with a demonstrated background in clinical trial start-up, regulatory submissions, and cross-functional collaboration. You possess a strong understanding of ICH-GCP, MHRA CTA, and the UK regulatory environment.
• You bring proven experience and hold a degree in life sciences (MD, PhD, MA/MS, BA/BS) or equivalent; a postgraduate or master's degree is highly desirable.
• You have extensive experience in clinical trial start-up processes, including regulatory submissions, site activations, and amendments.
• Proven leadership or line management experience, with a track record of coaching, motivating, and driving teams toward shared goals.
• Excellent communication and interpersonal skills.
• Proficiency in clinical systems such as Veeva Vault, CTIS, and RIM.
• The ability to lead through complexity and ambiguity in matrixed and global teams.
• Fluency in both written and spoken English.
• You demonstrate exceptional communication, organisational, and analytical problem-solving skills to navigate high-pressure, complex environments.

This role is based onsite at our Welwyn, United Kingdom office.

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.