Study Systems Lead

Roche; Welwyn; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global healthcare company is seeking a Study Systems Lead in Welwyn, UK, to enhance productivity and streamline clinical trial operations. The successful candidate will drive the implementation of study systems and oversee compliance, ensuring adherence to regulatory standards. They should possess extensive experience in clinical trial operations and be skilled at problem-solving and mentoring peers. This role offers the opportunity to influence global healthcare delivery within a hybrid work setting.

Qualifications

• Proven experience in clinical trials and compliance.
• Expertise in clinical operations infrastructure activities.
• Knowledge of ICH, GCP, and regulatory guidelines.

Responsibilities

• Drive clinical trial delivery and enhance productivity.
• Implement study systems and oversee performance.
• Lead continuous improvement and change management activities.

Skills

Clinical trial operations

Compliance and audit

Vendor management

Problem-solving

Mentoring and coaching

Job description

Position

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.

Opportunity

Your primary mission as a Study Systems Lead - Global Clinical Operations Excellence Manager will be to drive impact, enhance productivity, and enable seamless, efficient clinical trial delivery for patients, investigators, and clinical site staff.

• Be responsible for the implementation of program-wide study systems such as IRT and eCOA strategies and standards, overseeing process management and monitoring performance in collaboration with program leadership.
• Lead the identification and implementation of continuous improvement and change management activities, offering new perspectives to solve complex operational problems.
• Apply subject matter expertise in one or more areas—including Quality and Compliance, Business Process, or Knowledge Management—to address emergent, high-impact needs across Clinical Operations.
• Collaborate globally and cross-functionally across Quality, Early research and development functions, and external partners to optimize processes and ensure strong quality and compliance.
• Drive the adoption of innovative technologies, including leveraging data and Artificial Intelligence (AI), to promote new ways of working and fuel innovation in knowledge sharing and operational efficiency.
• Take accountability for GCP/GVP compliance, business process ownership, and data integrity, ensuring adherence to global and local regulatory guidelines. This role offers significant global influence and impact, with the opportunity to mentor and coach colleagues and lead parts of global infrastructure projects.

Who you are

You are an established professional with a comprehensive working knowledge of the infrastructure needed to conduct clinical trials, ready to take on complex challenges and drive strategic change.

• Typically, you have proven experience in clinical trial operations in process, compliance, audit and inspections, vendor management, systems, or learning.
• Demonstrated subject matter expertise on specific clinical operations infrastructure activities and experience in executing global clinical trials infrastructure projects.
• You possess and can apply proficient knowledge of ICH, GCP, and regulatory guidelines within clinical trials or enabling activities to ensure strong compliance.
• Capable of independently prioritizing your own work and effectively influencing the team to develop and execute plans for clinical trial infrastructure projects.
• You are skilled in solving complex outcomes, taking a new perspective on existing solutions, and exercising judgment based on analyzing multiple sources of information.
• Experience in mentoring and coaching less experienced colleagues and providing informal guidance is preferred.

Benefits and Location

This role is based on site at our Welwyn, United Kingdom office. Our team follows a hybrid work structure, requiring a fixed number of onsite days per week.

Who we are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advancing 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.