Clinical Trial Manager

Coopers Group AG seeks a Senior Clinical Trial Manager in Basel to lead regional trial operations across US, EU, and Asia-Pacific markets.

This position serves as a pivotal member of the Global Clinical Trial Team, bringing specialized regional expertise to oversee activities in the US, Canada, Europe, Latin America, and Asia-Pacific. The role is designed for a professional with extensive background in managing clinical trials at a regional level, ensuring alignment with local regulatory and operational standards.

Responsibilities

• Evaluate essential regional documentation, including FDA/IRB submissions, CTA/EC packages, and informed consent forms, to expedite site activation.
• Analyze responses from Ethics Committees and IRBs to provide rapid feedback and resolve submission hurdles.
• Serve as the main liaison for Regional and Country CRO teams, coordinating daily interactions and expectations.
• Act as a primary partner for trial sites, with a specific focus on supporting Clinical Research Coordinator staff.
• Track and monitor regional site milestones and metrics, including Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs).
• Monitor protocol deviations at regional sites, escalating potential risks and implementing corrective actions.
• Collaborate with the team to create and execute contingency plans for risk mitigation strategies.
• Identify ways to speed up trial start-up processes within the region and develop actionable plans to seize these opportunities.
• Join Site Selection Visits to assess potential locations, gathering input from other functional areas as necessary.
• Participate in Site Initiation Visits and routine monitoring visits to ensure compliance and progress.
• Conduct oversight visits alongside CRO monitors to verify that study personnel are qualified and appropriate.
• Engage in site audits when needed and assist in the implementation of Corrective and Preventive Actions (CAPA).
• Work with sites and Quality Assurance to ensure all clinical trial locations are prepared for regulatory inspections.
• Review protocol drafts and master/local informed consent documents as part of the development process.

Requirements

• Bachelor’s degree combined with at least 10 years of experience in pharmaceutical or biotech clinical development.
• Extensive background in managing regional or country-specific aspects of Phase I through IV clinical trials.
• Demonstrated experience in overseeing CROs and external vendors.
• Proven capability to collaborate effectively with large, interdisciplinary teams and external vendors.
• Strong command of Good Clinical Practice (GCP), ICH guidelines, and relevant regulatory requirements.

Nice to have

• Prior experience conducting trials for rare diseases.