Clinical Trial Manager, Oncology – FSP

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Serve as a key member of the sponsor's Development Operations team.

• Oversee individual clinical trials and/or programs as part of the Clinical Trial Working Group.

• Facilitate trial setup, execution, and delivery through meticulous planning and effective implementation.

• Manage relationships with external vendors and contract research organizations.

• Prepare essential study documents, including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.

• Coordinate and take ownership of study materials such as CRFs, patient diaries, study participation cards, and source documents.

• Assist in the development of protocols and the completion of study reports.

• Oversee monitoring activities, which may include routine on-site clinical monitoring, to ensure compliance with GCPs, SOPs, and study protocols.

• Provide guidance, direction, and management to Clinical Research Associates (CRAs).

• Track patient enrollment; qualify, initiate, monitor, and close out sites; review site reports; and assist with data management coordination.

• Coordinate the provision of study supplies.

• Negotiate contracts with clinical trial service providers.

• Review Informed Consent Forms, CRFs, and other study-related materials.

• Plan and take part in investigator meetings.

• Assist and support the data query process.

• Ensure regulatory compliance of investigational sites with sponsor SOPs and FDA and ICH guidelines.

• Maintain and ensure the trial master file is up-to-date and organized.

⛳️ Requirements

• A Bachelor’s degree, nursing degree, or equivalent is required; a science background is preferred.

• A minimum of 5 years of experience in clinical studies within the Pharmaceutical, Biotech, or CRO industries.

• Demonstrated success with relevant clinical trials experience, showcasing strong performance as a CRA in the pharmaceutical sector (i.e., biotechnology, pharmaceutical, CRO, medical device).

• Proven experience in managing clinical trials.

• Demonstrated ability to lead and manage people in a matrixed environment.

• Solid understanding of GCP, ICH guidelines and regulations, regulatory requirements, and clinical trial processes.

• Capability to work independently as well as collaboratively in a team setting.

• Proficient in MS Office applications (e.g., Word, Excel, PowerPoint, Outlook).

• Exceptional oral and written communication skills coupled with strong organizational abilities.

• Willingness to work outside of standard hours as necessitated by business needs.

🏝️ Benefits

• Option for remote work or a home-based arrangement within the UK.

• Opportunities for continuous learning and development.

• Possibilities for career path exploration and skill enhancement within clinical research.

• Flexibility and the environment to perform at their best.