Country Study Start-Up Team Leader

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

Title: Country Study Start-Up Team Leader (cSTL)

Locations: Welwyn

Country: United Kingdom

Time type: Full time

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 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 You will be responsible for leading the country's study start-up strategy, focusing on efficiency, innovation, and collaboration with external partners. Your work will have a direct impact on the speed and quality of our clinical trials. This role is internally known as the Country Study Start-Up Team Leader (cSTL).

Your key responsibilities will include:

• 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.

The ideal candidate will also have:

• 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.

Relocation benefits are not available for this job posting.

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.