Regional Clinical Study Manager

12 locations: Belgium – Denmark – France – Germany – Italy – Netherlands - Norway – Poland – Spain – Sweden – Switzerland – UK.

Overview:

On behalf of our client, a pharma-biotech company developing innovative oncology medicines, we are seeking a Regional Clinical Study Manager.

Primary Responsibilities:

• Ensure timely and high-quality regional study delivery, maintaining inspection readiness and adhering to agreed timelines and budget.
• Lead the regional clinical operations team, overseeing external partners at the regional level, and serve as the primary point of contact for issue resolution within the region.
• Align regional deliverables with overall study objectives.

Key Duties:

Regional Leadership

• Effectively lead the regional clinical operations team, facilitate decision-making, and address regional issues for the assigned study.
• Oversee external vendors participating in regional study delivery.
• Provide regular updates on regional study progress to senior management and the Global Clinical Study Manager.
• Represent the regional study team at internal and cross-functional meetings.

Timelines, Planning, and Execution

• Lead planning and management of assigned clinical studies from feasibility through closeout activities in the region, adhering to global timelines.
• Generate and maintain high-quality study start-up and recruitment timelines for the region, tracking progress accordingly.
• Ensure operational feasibility of the clinical study in the region, collaborating with stakeholders on trial feasibility, country allocation, and site selection.
• Provide regional input to global study plans as needed.
• Ensure timely submission of local adaptations of global study documents to regulatory authorities and ethics committees.
• { "@context" : "https://schema.org/", "@type" : "JobPosting", "title" : "Regional Clinical Study Manager", "description" : "

  Regional Clinical Study Manager

  12 locations: Belgium – Denmark – France – Germany – Italy – Netherlands - Norway – Poland – Spain – Sweden – Switzerland – UK.

  Overview:

  On behalf of our client, a pharma-biotech company developing innovative oncology medicines, we are seeking a Regional Clinical Study Manager.

  Primary Responsibilities:

  • Ensure timely and high-quality regional study delivery, maintaining inspection readiness and adhering to agreed timelines and budget.
  • Lead the regional clinical operations team, overseeing external partners at the regional level, and serve as the primary point of contact for issue resolution within the region.
  • Align regional deliverables with overall study objectives.

   

  Key Duties:

  Regional Leadership

  • Effectively lead the regional clinical operations team, facilitate decision-making, and address regional issues for the assigned study.
  • Oversee external vendors participating in regional study delivery.
  • Provide regular updates on regional study progress to senior management and the Global Clinical Study Manager.
  • Represent the regional study team at internal and cross-functional meetings.

   

  Timelines, Planning, and Execution

  • Lead planning and management of assigned clinical studies from feasibility through closeout activities in the region, adhering to global timelines.
  • Generate and maintain high-quality study start-up and recruitment timelines for the region, tracking progress accordingly.
  • Ensure operational feasibility of the clinical study in the region, collaborating with stakeholders on trial feasibility, country allocation, and site selection.
  • Provide regional input to global study plans as needed.
  • Ensure timely submission of local adaptations of global study documents to regulatory authorities and ethics committees.
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