Clinical Trial Manager — CRO & Vendor Oversight

CDR-Life AG; Horgen; In loco; CHF 120.000 - 170.000; Tempo pieno

Descrizione del lavoro

CDR-Life AG is seeking a Clinical Trial Manager to direct and support planning and management of clinical trials in an outsourced environment. You will oversee CRO relationships, vendor performance, and study documentation while ensuring compliance with ICH-GCP and regulatory requirements.

The role requires a hands-on leader who can own operational issues, manage external partners, and thrive in a dynamic biotech setting. Travel may be required as part of global trial oversight.

Competenze

• Master's degree or higher in life sciences, healthcare or related discipline.
• > 2 years of experience managing clinical trials in biotech/pharma/CRO environments (excluding monitoring).
• Experience with management and oversight of CROs and vendors.
• Clinical site monitoring experience (CRA), preferably in oncology.
• Robust understanding of global multi-center trial operations.
• Solid knowledge of drug development regulations (ICH-GCP, EMA, FDA, local regulations).
• Ability to travel on short notice.

Mansioni

• Manage and/or support the operational planning and execution of clinical trials from study start-up through conduct and close-out.
• Act as a key operational contact for CROs, clinical sites, and other external vendors.
• Manage and oversee CRO and vendor activities, deliverables, timelines, quality, and budgets, including escalation of performance issues.
• Participate in CRO/vendor selection, bid-defense activities, contracting and periodic performance assessments.
• Support country and site feasibility, selection, activation, management, and close-out activities.
• Maintain in-depth knowledge of the study protocol, operational requirements, and study plans.
• Develop, review, and maintain study plans, manuals, trackers, and other trial-specific documentation.
• Conduct sponsor co-monitoring visits and review monitoring visit reports to ensure appropriate site oversight and monitoring quality.
• Oversee study budgets, forecasts, invoices, purchase orders, and change orders as applicable.
• Support the set-up, testing, and maintenance of trial systems (EDC, IRT, eTMF, etc.).
• Provide clear and timely study status updates to internal stakeholders and senior management.
• Maintain knowledge of applicable clinical trial regulations and ensure studies comply with ICH-GCP and company procedures.

Conoscenze

Communication skills

Clear writing

Detail oriented

Organizational skills

Time management

Independent worker

Team player

Formazione

Master's degree or higher in life sciences/healthcare

Descrizione del lavoro

CDR-Life AG is seeking a Clinical Trial Manager to direct and support planning and management of clinical trials in an outsourced environment. You will oversee CRO relationships, vendor performance, and study documentation while ensuring compliance with ICH-GCP and regulatory requirements.

The role requires a hands-on leader who can own operational issues, manage external partners, and thrive in a dynamic biotech setting. Travel may be required as part of global trial oversight.