Global Study Lead (Molecular Lab) at Roche

Motherwell, Scotland, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

23 Aug, 26

Salary

0.0

Posted On

25 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Study Design, Budget Control, Vendor Management, CRO Management, Protocol Development, Regulatory Compliance, Clinical Operations, Stakeholder Management, Companion Diagnostics, Molecular IVD, Project Management

Industry

Biotechnology Research

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 At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally. We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster. Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life. The Opportunity As a Global Study Lead, you will take full accountability for the design, planning, and execution of global sponsored clinical trials from protocol development through to close-out. Joining a dynamic, matrixed team within our Clinical Development and Medical Affairs communities, you will oversee diverse study portfolios, including companion diagnostics, early adopter programs, and research collaborations, ensuring operational excellence, budget control, and absolute inspection readiness. Drive Study Excellence: Lead the global cross-functional study team with full accountability for high-quality study designs, clinical deliverables, budgets, and timelines. Shape Evidence Strategies: Partner with Program Leadership to map out innovative scenarios for global evidence generation, collaborating across Regulatory Affairs, R&D, and medical project teams. Author Core Study Documentation: Develop critical, high-impact clinical documents including study protocols, Design Validation Plans, study forms, and comprehensive study reports. Champion Strategic Partnerships: Oversee external service providers and Contract Research Organisations (CROs), driving vendor performance, selection, and relationship management at the study level. Advance Diagnostics Innovation: Direct the operational aspects of companion diagnostics studies sponsored by external partners alongside early access and research collaboration portfolios. Cultivate Expert Networks: Collaborate closely with international medical opinion leaders, investigators, and key external stakeholders to bring advanced external insights in-house. Who You Are You are a proactive, analytical clinical operations professional who thrives in fast-paced, global environments. You bring a collaborative mindset, excellent communication skills, and a passion for delivering life-changing clinical insights. A degree in Life Sciences, Healthcare, or a related scientific field (an advanced degree is a plus). Strong, progressive experience in clinical trial management or study-level execution within the healthcare, pharmaceutical, or biotechnology sectors. Preferably experience study managing Molecular IVD clinical trials. Solid working knowledge of clinical research standards and global regulations (such as ICH-GCP, IVDD/IVDR, MDR, SaMD, or FDA frameworks). Demonstrated ability to manage external suppliers (like CROs) and successfully manage complex project budgets. Exceptional verbal and written communication skills in English, with a proven ability to lead project substreams, build consensus, and work fluidly across diverse regions and cultures. Together, we’ll advance along the whole patient journey with the aspiration to prevent, stop and cure diseases. Apply today to help us shape the future of clinical operations! Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Burgess Hill. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

The Global Study Lead is accountable for the design, planning, and execution of global sponsored clinical trials from protocol development to close-out. This includes leading cross-functional teams, managing budgets, and overseeing external service providers and CROs.