Freelance Study Manager

Proclinical; City Of London; On-site; GBP 70,000 - 110,000; Full time

Job summary

Proclinical is seeking a Freelance Study Manager to oversee and deliver early-phase clinical study operations across a cross-functional team, ensuring execution aligns with timelines and regulatory standards. You will contribute to protocol design, oversee site start-up, country selection, and patient-centric planning while maintaining essential documentation and study systems.

This role requires strong ICH-GCP knowledge, vendor management experience across multiple countries, proactive

Qualifications

• Experience leading early-phase clinical studies and driving cross-functional execution.
• Deep knowledge of drug development processes, ICH-GCP, and regulatory requirements.
• Experience coordinating multi-country studies and managing vendors.

Responsibilities

• Oversee and deliver early-phase clinical study operations.
• Contribute to protocol design, feasibility assessments, country selection, and patient-centric planning.
• Maintain study documentation including informed consent forms, Trial Master File, and monitoring plans.
• Provide country-level oversight to support site start-up and patient recruitment.
• Manage vendor and third-party performance, ensuring adherence to scope and SOPs.
• Forecast and manage study supplies including IMP.
• Identify, mitigate, and track study risks and issues with implemented solutions.
• Drive continuous improvement and operational excellence across study processes.

Skills

Clinical study management

ICH-GCP guidelines

Multi-country studies

Vendor management

Regulatory compliance

Communication

Analytical mindset

Life sciences degree

Education

Bachelor's degree in Life Sciences

Tools

eTMF systems

CTMS/EDC familiarity

Job description

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.