Clinical Site Manager (Oncology)

Roche•Pleasanton, CA

1d•Remote

About The Position

As a Clinical Site Manager for the Study Delivery Oncology Team, you are responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at clinical study sites. This role also involves delivering other data generation methodologies, working 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 position is primarily located in Pleasanton, but applicants from any part of the US are encouraged to apply.

Requirements

Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of education and work experience)
3 years of working experience in either the Medical Device or Diagnostics industry
2 years of working experience in clinical study of IVD/Medical Device/Drug
Excellent understanding of ICH GCP guidelines in the execution of clinical trials
Ability to make sound decisions and to analyze and solve problems; makes independent choices and takes responsibility
Flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial.

Responsibilities

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 the site selection decision process and site activation activities, 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.
Participate in and oversee CRO delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers.
Mentor and support colleagues to enhance their skills and expertise.
Validate product performance claims, supply data for critical regulatory submissions, define the functional and clinical utility of products, and gather feedback and opinions from laboratories or customers regarding the products.
Execute site management activities for sponsored studies in assigned focus areas across all phases of study (start-up, conduct, and 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, collaborative relationships with cross-functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence.