The PositionThe OpportunityAs a Clinical Site Manager specialising in Study Start-Up, you will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating clinical research studies at assigned sites. You will work independently to ensure studies are delivered, recorded, and reported in accordance with protocols, standard operating procedures, and global regulatory guidelines.
In this role, you will:
- Lead end-to-end study start-up activities, driving site identification, selection, and activation to ensure clinical trials launch efficiently and are compliance-ready.
- Manage Ethics Committee (EC) and Competent Authority (CA) and/or InvestigationInstitutional Review Board (IRB) submissions, ensuring all trial documentation, local contracts, and institutional approvals meet stringent regulatory timelines.
- Act as the primary contact and clinical trial expert for start-up activities for assigned study site personnel, and coordinate necessary certifications.
- Develop critical study documentation, including informed consent documents, patient instruction guides, etc
- Collaborate cross-functionally with global, local, and virtual teams to help deliver top-tier clinical diagnostic solutions.
- Foster a culture of belonging by partnering across diverse regions, cultures, and time zones to build inclusive team environments.
Who You AreYou are a proactive, collaborative, and highly organised clinical research professional who thrives in a fast-paced, matrixed environment. You possess strong problem-solving skills, make sound independent decisions, and excel at managing external vendor relationships.
To be successful in this role, you bring:
- Education & Experience: A degree in a scientific discipline or related field (or equivalent combination of education and experience) combined with a proven track record in clinical operations or clinical trial coordination.
- Study Start-Up & Submission Expertise: Hands-on experience navigating diagnostic and medical device trials, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions.
- Stakeholder Engagement: Exceptional verbal and written communication skills (English) with a proven ability to build trusted relationships and influence cross-functional partners.
- German speaking is a plus.
At Roche, you’ll thrive in a culture that values different perspectives and creates a place of belonging, where we challenge ourselves to excel and achieve strong results, together. Let’s create a healthier, brighter future for all.
Behaviors, competencies, and qualities of the ideal applicant.
- Exhibits the ability to make sound decisions and to analyze and solve problems; makes independent choices and takes responsibility
- Demonstrates flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is cruci
Relocation Benefits are not offered for this job posting since the role is remote.
The expected salary range for this position based on the primary location of Pleasanton 90,900 - 142,780 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 detailed at the link provided below.
