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.
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Freelance Study Manager in City of London employer: ProClinical
Join a globally recognised biopharmaceutical organisation that prioritises innovation and collaboration in the field of protein science and biologic drug development. With a strong commitment to employee growth, you will have access to continuous learning opportunities and be part of a supportive team dedicated to delivering life-changing therapies. Located in a vibrant area, this role not only offers meaningful work but also a dynamic work culture that values your contributions and fosters professional development.
