Clinical Site Manager (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

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Trial Management, Site Assessment, Regulatory Compliance, Data Validation, Study Monitoring, ICH-GCP, FDA Regulations, IVDR, Clinical Lab Coordination, Technical Writing, Cross-functional Collaboration, Project Planning, Site Activation, Molecular Diagnostics, Analytical Problem Solving, Stakeholder 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 Clinical Site Manager specialising in our molecular lab portfolio, you will be responsible for designing, planning, coordinating, and conducting clinical research studies across assigned sites. Working independently, you will serve as the primary clinical trial expert, ensuring data generation methodologies are delivered in alignment with global quality protocols. This role offers an exciting opportunity to validate product performance claims, supply crucial data for regulatory submissions, and directly help deliver innovative diagnostic solutions to patients worldwide. Key Responsibilities: Lead Site Execution: Act as the primary contact and clinical trial expert for assigned study site personnel, delivering technical assistance and coordinating necessary training. Conduct Site Assessments: Perform comprehensive site assessments and qualification visits to drive informed site selection decisions. Manage Site Activation: Collaborate cross-functionally to ensure investigational sites properly obtain and maintain institutional approvals and meet all regulatory compliance needs before trial initiation. Develop Essential Documentation: Author and review key study site documents, including Study Monitoring Plans, informed consent forms, and case report forms, while contributing technical expertise to study protocols. Deliver End-to-End Monitoring: Execute all data generation, data validation, and comprehensive site visits across all study phases, from start-up through to close-out. Partner Cross-Functionally: Work dynamically within local, global, and virtual study teams, collaborating with R&D, Field Service, Study Management, and Biometrics to deliver top-tier solutions. Support Process Optimisation: Contribute to continuous improvement and change management activities to bring fresh perspectives to existing diagnostic testing solutions. Who You Are You are a proactive, adaptable professional who thrives in a fast-paced, matrixed environment. You bring strong analytical and problem-solving skills, make independent, sound choices, and possess a natural ability to build consensus across diverse teams. Education & Lab Familiarity: A Bachelor's degree in a scientific discipline or a related field (or an equivalent combination of education and experience). Hands-on experience in a clinical laboratory or clinical lab study coordination is highly valued. Clinical Operations Foundations: Typically brings professional experience, with solid conceptual and practical knowledge of clinical operations or diagnostic product development. Regulatory Compliance: Good knowledge of, and strict adherence to, clinical trial and laboratory standards, including ICH-GCP guidelines, FDA Regulations, and IVDR. Global Collaboration: Proven ability to partner across diverse regions, cultures, and time zones to cultivate an environment of belonging, inclusion, and diversity. Communication Skills: Exceptional verbal and written communication skills in English, allowing you to explain complex data clearly in straightforward situations. Ready to make a difference? Help us achieve our ambition: to advance science, so that we all have more time with the people we love. Apply today and help us shape the future of healthcare! 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 role involves designing, planning, and coordinating clinical research studies for molecular lab portfolios across assigned sites. Key duties include leading site execution, conducting assessments, and ensuring data generation aligns with global quality protocols.