Position
Clinical Site Manager – Study Delivery Near Patient Care CVMD Team (Roche Diagnostics Solutions)
Location
Motherwell, UK
Responsibilities
* Design, plan, coordinate, and conduct all activities involved in initiating, monitoring, and completing clinical research studies at clinical study sites.
* Act 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.
* Perform site assessments and qualification visits to support site selection and activation, including contracting and obtaining IRB/EC/Health Authority approvals in compliance with regulatory requirements.
* Develop and manage key study site documentation such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms; contribute technical expertise to review study protocols, data management plans, reports, and manuscripts.
* Oversee CROs for delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues.
* Execute site management activities for sponsored studies across all phases (start‑up, conduct, close‑out) for both registrational and non‑registrational purposes.
* 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 regarding the products.
* Work 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.
Qualifications
* Bachelor’s degree in Science, preferably in Health Sciences such as Clinical Diagnostics, Engineering, or an equivalent combination of education and work experience.
* Working experience in the Medical Device or Diagnostics industry, with experience in clinical study of IVD, Medical Device, or Drug products.
* Experience particularly in cardiovascular/metabolic indications and Near Patient Care or Point of Care settings; experience in an emergency department setting is a plus.
* Excellent understanding of ICH GCP guidelines in the execution of clinical trials.
* Demonstrated ability to make sound decisions, analyze and solve problems, take independent choices and responsibility.
* Demonstrates flexibility and adaptability to perform in a fast‑paced, matrixed environment where fluid, cross‑team collaboration is crucial.
Roche is an Equal Opportunity Employer.
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