Freelance Study Manager

Lead Early-Phase Clinical Study Operations

Thrive in leading early-phase clinical studies from start to finish while ensuring operational excellence and regulatory compliance. This role involves overseeing and delivering early-phase clinical study operations as part of a collaborative cross-functional team, managing study execution, ensuring compliance with regulatory standards, and driving operational excellence.

Key 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.

Essential 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.