Clinical Site Manager

Roche•Indianapolis, IN

4d•Onsite

About The Position

At Roche, we foster a culture where individuals are embraced for their unique qualities, encouraging personal expression, open dialogue, and genuine connections. We value, accept, and respect everyone, enabling them to thrive personally and professionally. Our mission is to prevent, stop, and cure diseases and ensure universal access to healthcare. The Clinical Site Manager is responsible for the design, planning, coordination, and execution of all activities related to initiating, monitoring, and completing clinical research studies at clinical study sites. This role ensures studies are conducted, recorded, and reported in compliance with the protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. The position involves acting as the primary contact and clinical trial expert for assigned study site personnel, providing training, coordinating certification, and offering technical assistance. It includes performing site assessments, participating in site activation processes (contracting, IRB/EC/Health Authority approvals), and developing key study site documents. Collaboration with cross-functional teams such as R&D, Field Service, Study Management, and Biometrics is essential for delivering optimal solutions. The role encompasses end-to-end site visits for data generation/validation and site monitoring, potentially overseeing CRO delivery of Site Management activities, and interacting with international investigators and key customers. Coaching colleagues and contributing to their skill development may also be part of the role. The Clinical Site Manager is accountable for the site-level budget of assigned sites and works independently.

Requirements

Bachelor’s degree in a scientific discipline
3 years of experience in a regulated, CRO, diagnostic and or pharmaceutical industry
Adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness.
Prior experience with clinical trial management and bio-sample (clinical testing) management and quality assurance
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.
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).
Worked in local and global study teams, including virtual teams and exhibit diversity and cultural awareness.
Built and maintained strong, collaborative relationships with cross-functional team members, relevant internal and external stakeholders , in meeting business goals and ensuring operational excellence.

Nice To Haves

Experience working in a clinical laboratory environment or clinical lab study
Experience in In Vitro Diagnostics (IVD) and Clinical Research Associate (CRA) operations.
Experience with Ultra/Ultra Plus instrumentation and complex data transfer protocols.
Prior experience within Companion Diagnostics

Responsibilities

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