Clinical Study Manager

About the role

Roche is seeking a Clinical Study Manager to lead operational execution of secondary data use Real World Evidence (RWE) activities and international clinical studies. You will coordinate end‑to‑end study operations across global sites, ensuring high‑quality, safe, and ethical data delivery.

Key responsibilities

• Build and guide cross‑functional, borderless study teams, defining clear accountabilities and fostering a psychologically safe environment.
• Maintain comprehensive study plans, risk mitigation strategies, site selection procedures, and vendor oversight from activation through clinical closure.
• Manage study budgets, track metrics, review work orders, and negotiate agreements to achieve cost‑effective operations.
• Ensure compliance with international clinical trial guidelines, Good Pharmacovigilance Practices, Good Pharmacoepidemiology Practices, and local regulations.
• Oversee external vendors, monitor performance metrics, resolve operational issues, and coordinate necessary training.
• Analyze trial feasibility data across multiple countries to develop strategic recruitment, site distribution, patient enrollment, and retention plans.

Required profile

• Proactive, strategic operational leader with a growth mindset and strong problem‑solving abilities under tight deadlines.
• Demonstrated experience leading study teams through all operational stages of clinical studies or secondary data use projects.
• Deep understanding of global clinical quality requirements, regulations, and pharmacovigilance standards.
• Excellent listening and empathy skills that inspire and support team members.
• Ability to develop and execute strategic planning and risk‑management initiatives.

Required skills

• Knowledge of Good Pharmacovigilance Practices (GPvP) and Good Pharmacoepidemiology Practices (GPP).
• Familiarity with international clinical trial regulations and compliance frameworks.