Freelance Study Manager

Do you thrive in leading early-phase clinical studies from start to finish while ensuring operational excellence and regulatory compliance?

Proclinical is seeking a Freelance Study Manager to oversee and deliver early-phase clinical study operations as part of a collaborative cross-functional team. This role involves managing study execution, ensuring compliance with regulatory standards, and driving operational excellence.

Responsibilities:

• Manage and execute early-phase clinical studies, ensuring smooth operations within a cross-functional team.
• Contribute to protocol design, feasibility assessments, country selection, and patient-centric planning.
• Maintain study systems and essential documentation, including informed consent forms, Trial Master File, and monitoring plans.
• Provide country-level oversight to support site start-up and patient recruitment efforts.
• Oversee vendor and third-party supplier performance, ensuring adherence to contracted scope, ICH-GCP guidelines, and SOPs.
• Forecast and manage study supplies, including investigational medicinal products (IMP).
• Identify, mitigate, and track study risks and issues, implementing solutions to ensure project success.
• Drive continuous improvement and operational excellence across study processes.

Key Skills and Requirements:

• Proven experience in clinical study management or equivalent roles within pharmaceutical or healthcare drug development.
• Strong knowledge of drug development processes, regulations, and ICH-GCP guidelines.
• Experience managing multi-country studies and collaborating with vendors.
• Proactive communication skills and the ability to work effectively within a team.
• Analytical mindset with strong problem-solving capabilities.
• A university degree or equivalent experience, preferably in life sciences.
  

If you are having difficulty in applying or if you have any questions, please contact Camille Sandres at c.sandres@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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