The role
As 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.
At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
What you need
You 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.
Pay and benefits
Roche didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Discretionary annual bonus
Benefits package
From the posting
About Roche
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
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.
Equal opportunity, accessibility and legal noticesRoche's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 14, 2026
Salary intelligence
How the pay compares
Manager roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $149,500 | $154,500 | $159,250 |
Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 105 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Roche's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct6
- Collaboration and leadership6
- Documentation and SOPs4
- Regulatory submissions2
- Data and digital systems2
- GMP and compliance1
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigationsNamed in the posting
- ISOISO 14155(official source, opens in a new tab)Good clinical practice for clinical investigations of medical devices
- FDA21 CFR Part 812(official source, opens in a new tab)Investigational device exemptions for clinical studies of devices
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- EUMDCG guidance(official source, opens in a new tab)The Medical Device Coordination Group's endorsed guidance on applying the MDR and IVDR
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDA21 CFR Part 803(official source, opens in a new tab)Medical device reporting of deaths, serious injuries and malfunctions
- FDAFDA Q-Submission Program(official source, opens in a new tab)Pre-Submissions and meetings with FDA on device submissions
Company hiring pulse
Roche on Regulatory Jobs
- 9
- Open roles
- 9
- Distinct roles
- 5
- Locations
By discipline
- Clinical4 44%
- Regulatory3 33%
- Quality2 22%
By level
- Manager3 33%
- Senior & Principal3 33%
- VP & Executive2 22%
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Clinical Site Manager at Roche
Applications close November 19.