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Clinical Site Manager
RocheClinical Site Manager managing clinical research studies and supporting regulatory processes at Roche. Responsible for site selection, training, and cross-functional collaboration to ensure operational excellence.
Posted 5/28/2026full-timeTucson • Arizona • 🇺🇸 United StatesMid-LevelSenior💰 $79,000 - $146,800 per yearWebsite
About the role
Key responsibilities & impact- The Clinical Site Manager is responsible for designing, planning, coordinating and conducting all activities involved in initiating, monitoring, and completing clinical research studies in the clinical study sites and delivering as appropriate other data generation methodologies.
- Act as primary contact and clinical trial expert for assigned study site personnel for execution of the study - including training and coordinating certification of study site personnel and providing technical assistance, as necessary.
- Perform site assessments/site qualification visits in the site selection decision process.
- May participate in and ensure site activation (contracting, IRB/EC/Health Authority approvals are, etc.) are properly obtained, maintained and meet regulatory requirements in collaboration with relevant RDS Functions prior to initiation of the investigational site.
- Develop key study site documents (e.g. Study Monitoring Plan, informed consent documents, source documents, patient instruction guides and case report forms, etc.) and contribute technical expertise in the review of study protocols, data management plans, reports and manuscript, etc.
- Collaborate cross-functionally with R&D, Field Service, Study Management, Biometrics, etc. to deliver best solutions.
- Deliver all data generation/validation and site monitoring activities including end-to-end site visits per relevant regulations and processes.
- May participate in the oversight of CRO delivery of Site Management activities, including training of CRO CRAs. This includes escalation of any issues.
- May work with international investigators and key customers as well.
- May coach colleagues and help others develop expertise/skills
- Accountable for site-level budget of assigned sites
- Work independently and is autonomous
Requirements
What you’ll need- You have a Bachelor’s degree in a scientific discipline
- You have 3 years of experience in a regulated, CRO, diagnostic and or pharmaceutical industry
- You adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness.
- You have prior experience with clinical trial management and bio-sample (clinical testing) management and quality assurance
- You have prior experience validating product performance claims, supplying data for critical Regulatory submissions, defining the functional and clinical utility of our products, and obtaining the opinions and input regarding our products from laboratories or customers.
- You have executed Site Management activities for sponsored studies for assigned areas of focus for registrational and/or non-registrational purposes through all study phases (start-up, conduct and close-out).
- You have worked in local and global study teams, including virtual teams and exhibit diversity and cultural awareness.
- You have built and maintained strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders , in meeting business goals and ensuring operational excellence.
Benefits
Comp & perks- A discretionary annual bonus may be available based on individual and Company performance
- Benefits detailed at the link provided
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical trial managementbio-sample managementquality assurancesite management activitiesdata generation methodologiesregulatory submissionsstudy protocol reviewdata management planscase report formssite qualification visits
Soft Skills
collaborative relationshipscross-functional collaborationcoachingcultural awarenessindependenceautonomycommunicationproblem-solvingtrainingleadership