Clinical Site Manager

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. Work 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 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. Who You Are 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. Preferred Experience You have experience working in a clinical laboratory environment or clinical lab study. You have experience in In Vitro Diagnostics (IVD) and Clinical Research Associate (CRA) operations. You have experience with Ultra/Ultra Plus instrumentation and complex data transfer protocols. You have prior experience within Companion Diagnostics. Relocation benefits are not available for this posting. The expected salary range for this position based on the primary location of Tucson-Off Campus is $79,000-146,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This position also qualifies for the benefits described in our benefits plan. Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr