Clinical Site Manager (Molecular Lab)

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 Bachelors 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!

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets 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.