Clinical Site Manager – Study Delivery CVMD Core Lab SWA Systems & Automation
At Roche Diagnostics Solutions (RDS) we are building a new core laboratory system to support early, faster, and fully personalized patient care. The Clinical Site Manager will be responsible for designing, planning, coordinating, and conducting all activities required to initiate, monitor, and complete clinical research studies at assigned study sites. The role requires delivering accurate data generation, ensuring compliance with protocol, SOPs, GCP, and regulatory requirements, and serving as the primary clinical trial expert for the site.
Responsibilities
- Design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies at the study site.
- Deliver other data generation methodologies, ensuring studies are completed, recorded, and reported in accordance with protocol, SOPs, GCP, and applicable regulatory requirements.
- Act as the primary contact and clinical trial expert for assigned site personnel, coordinating training, certification, and providing technical assistance to ensure successful study execution.
- Perform site assessments and qualification visits to support site selection and activation activities, including contracting and obtaining IRB/EC/Health Authority approvals.
- Develop and manage key study site documentation such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms.
- Participate in and oversee CRO delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring colleagues.
- Validate product performance claims, supply data for critical regulatory submissions, define the functional and clinical utility of products, and gather feedback from laboratories or customers.
- Execute site management activities for sponsored studies across all phases of study (start‑up, conduct, close‑out) for both registrational and non‑registrational purposes.
- Work in local and global study teams, including virtual teams, demonstrating diversity, cultural awareness, and fostering strong relationships with cross‑functional team members, internal stakeholders, and external partners.
Qualifications
- Bachelor’s degree in Science, preferably in Health Sciences such as Clinical Diagnostics or Engineering, or equivalent education and work experience.
- Experience in the Medical Device or Diagnostics industry and in clinical studies of IVD/Medical Device/Drug.
- Experience particularly in 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.
- Ability to make sound decisions, analyze and solve problems, take independent responsibility, and make independent choices.
- Demonstrated flexibility and adaptability to perform in a fast‑paced, matrixed environment with fluid cross‑team collaboration.
Location
Burgess Hill
EEO Statement
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 are committed to building a diverse and flexible working environment and are an equal opportunity employer.
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