Global Study Lead (Core Lab, Cardiovascular & Metabolic Diseases)

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.

We are looking for a dynamic and experienced Global Study Lead to join our this pivotal role you will lead global study teams to ensure the successful execution of clinical studies. You will be responsible for delivering high-quality study designs adhering to timelines and budgets and collaborating with cross-functional teams to support evidence generation strategies.

If you have a passion for advancing clinical trials in the cardiovascular/metabolic disease area (CVMD) specifically in Core Lab SWA (Serum Work Area) Systems and Automation we would love to hear from you!

Key Responsibilities:

• Lead and oversee the global study team ensuring full accountability for study deliverables including quality budget and timelines.

• Collaborate with Program Leadership to prepare different scenarios for evidence generation (e.g. study real-world evidence) and ensure cross-functional cooperation with Regulatory Affairs R&DBiostatistics Data Management and CDMA Project Teams.

• Develop key study documents such as Design Validation Plans study protocols training materials study forms templates and study reports.

• Maintain responsibility for the study-level budget of assigned studies.

• Ensure compliance with regulations guidelines and standard operating procedures while ensuring audit/inspection readiness.

• Oversee execution of sponsored studies for registrational and non-registrational purposes through all study phases (planning start-up conduct and close-out).

• Manage study activities outsourced to service providers including CROs ensuring timely and quality execution.

• Work with the Publication Team to ensure study results are effectively published.

• Track project performance and ensure that projects are completed on time within scope and within budget.

• Build and maintain strong collaborative relationships with internal and external stakeholders including cross-functional teams CROs opinion leaders investigators and key customers.

Who are you:

• Strong experience in clinical trial management particularly in the cardiovascular/metabolic indication. Experience with IVD clinical and analytical system studies in the Core Lab Serum Work Area setting is a plus.

• You have a degree in Life Sciences Healthcare or a related field. A background in multiple disease areas is a plus.

• You have practical knowledge of clinical trial management and product development with a solid understanding of Clinical Operations.

• Ability to lead and manage projects and provide guidance to less experienced colleagues.

• Strong analytical skills to solve complex problems and provide innovative solutions.

• Youre able to explain difficult or sensitive information and build consensus among stakeholders.

• You have a proven ability to build and maintain relationships with internal teams external partners and key stakeholders including CROs and international opinion leaders.

If youre looking to make a significant impact in a leading global healthcare organisation and have the required experience and qualifications we invite you to apply today.

Please upload only your current compelling CV and / or Cover Letter. We look forward to receiving your application!

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 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.

Employment Type : Full-Time
Experience: years
Vacancy: 1