Clinical Trial Manager – FSP

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

📋 Description

• Oversee external vendors and contract research organizations.

• Develop study documentation including the Monitoring Manual, Study Operations Manual, Source Data Verification Plan, and Laboratory Manual.

• Organize and take charge of the creation of study materials such as CRFs, patient diaries, study participation cards, and source documentation.

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

• Manage monitoring activities, which may involve routine on-site clinical monitoring at clinical study sites to ensure compliance with Good Clinical Practices (GCPs), SOPs, and study protocols.

• Offer guidance, direction, and oversight to Clinical Research Associates (CRAs).

• Monitor patient enrollment; qualify, initiate, oversee, perform closeout activities, and review site reports; and assist in the coordination of data management operations.

• Coordinate the distribution of study supplies.

• Negotiate contracts with vendors providing clinical trial services.

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

• Organize and take part in investigator meetings.

• Support and assist with the data query process.

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

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

⛳️ Requirements

• Required: Bachelor’s degree in nursing or equivalent; a science degree is preferred.

• Minimum of 5 years of experience in the clinical research industry (Pharmaceutical, Biotech, or CRO).

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

• Proven experience in managing clinical trials.

• Experience in CNS and/or oncology preferred.

• Demonstrated leadership and management skills in a matrixed environment.

• Experience managing global clinical trials.

• Strong working knowledge of GCP, ICH guidelines, and FDA regulations.

• Ability to work both independently and as part of a team.

• Willingness to travel 15-25%, including international travel.

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

• Excellent oral and written communication skills along with strong organizational abilities.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible working hours

• Paid time off