Clinical Site Manager (Core Lab, Cardiovascular & Metabolic Diseases) 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 Site Management, ICH GCP Guidelines, Site Assessment, CRO Management, Clinical Trial Execution, Regulatory Compliance, Study Monitoring, IVD Clinical Studies, Cardiovascular Indication, Metabolic Diseases Indication, Technical Assistance, Data Generation Methodologies, Site Qualification, Case Report Forms, Protocol Review, Cross-functional Collaboration

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. As a Clinical Site Manager for the Study Delivery CVMD Core Lab SWA Systems & Automation team, you are designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites. You are delivering other data generation methodologies, working independently to ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. The Opportunity Acting as the primary contact and clinical trial expert for assigned study site personnel, coordinating training, certification, and providing technical assistance to ensure successful study execution. Performing site assessments and qualification visits to support the site selection decision process and site activation activities, including contracting and obtaining IRB/EC/Health Authority approvals in compliance with regulatory requirements. Developing and managing key study site documentation, such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms, while contributing technical expertise to review study protocols, data management plans, reports, and manuscripts. Participating in and overseeing CRO delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues to enhance their skills and expertise. Validating product performance claims, supplying data for critical regulatory submissions, defining the functional and clinical utility of products, and gathering feedback and opinions from laboratories or customers regarding the products. Executing site management activities for sponsored studies in assigned focus areas across all phases of study (start-up, conduct, and close-out) for both registrational and non-registrational purposes. Working in local and global study teams, including virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross-functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence. Who You Are You bring a Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of education and work experience) You have experience in either the Medical Device or Diagnostics industry, and experience in clinical study of IVD/Medical Device/Drug. You have experience 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. Excellent understanding of ICH GCP guidelines in the execution of clinical trials You exhibit the ability to make sound decisions and to analyse and solve problems; make independent choices and take responsibility. You demonstrate flexibility and adaptability to perform in a fast-paced, matrixed environments where fluid, cross-team collaboration is crucial. Our combined strength in pharmaceuticals and diagnostics offers you a unique opportunity to create innovative solutions that transform patient care. At Roche, we aim high to deliver life-changing healthcare solutions. If you’re ready to make a meaningful impact on patients and healthcare systems worldwide, this is the place for you! 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 all activities for initiating and completing clinical research studies at study sites. Key duties include acting as the primary contact for site personnel, managing study documentation, and overseeing CRO delivery of site management activities.