Clinical Site Lead - Trials & Global Collaboration

Roche; Indianapolis (IN); On-site; USD 79,000 - 147,000; Full time

Benefits offered by this job

Discretionary annual bonus

Job summary

Roche Diagnostics Solutions is seeking a clinical trial expert to support study sites, coordinate training, and ensure compliant execution of trials. The role partners with global teams to advance data quality and patient safety.

The ideal candidate has a health-science degree, 3+ years in medical device/diagnostics trials, and solid ICH-GCP knowledge. Based in Indianapolis, the position emphasizes cross-functional collaboration and outcomes-driven execution.

Qualifications

• Bachelor’s degree in Health Science, Clinical Diagnostics, or engineering.
• 3+ years in Medical Device/Diagnostics clinical studies.
• 1+ year in cardiovascular/metabolic/POC settings.
• Solid understanding of ICH-GCP guidelines.
• Strong decision-making in fast-paced team settings.

Responsibilities

• Act as primary clinical trial expert for assigned sites, coordinating training and support.
• Conduct site assessments and activations, including IRB/EC/regulatory steps.
• Develop study site docs (MON Plans, consent forms, source docs) and review protocols.
• Oversee CROs, escalate issues, and liaise with international investigators.
• Manage site activities across startup to close-out for registrational studies.
• Provide data for regulatory submissions and collect feedback from labs and sites.
• Collaborate in cross-functional teams to foster an inclusive, high-performing environment.

Skills

ICH-GCP knowledge

Clinical trial execution

Site management

Regulatory compliance

Decision-making

Education

Bachelor’s degree in Health Science

Job description

Roche Diagnostics Solutions is seeking a clinical trial expert to support study sites, coordinate training, and ensure compliant execution of trials. The role partners with global teams to advance data quality and patient safety.

The ideal candidate has a health-science degree, 3+ years in medical device/diagnostics trials, and solid ICH-GCP knowledge. Based in Indianapolis, the position emphasizes cross-functional collaboration and outcomes-driven execution.