Clinical Trial Manager

Academic organization conducting groundbreaking scientific research.

Background:

An investigator-led clinical trial is being conducted to evaluate the effectiveness of a SARS-CoV-2 vaccine. The study is part of a larger international consortium. A Clinical Trial Manager (CTM) is needed to oversee the trial and will report to the project coordinator within the consortium.

Key Responsibilities:

The CTM will manage the clinical trial from preparation through to completion, ensuring that it is conducted within quality standards, timelines, and budget, in accordance with applicable procedures and regulations. The CTM will establish and maintain timelines and budgets, oversee external partners, and manage risks, problem resolution, contingency planning, and decision-making.

Responsibilities include:

• Ensure the clinical trial is conducted according to protocol requirements, study plans, internal procedures, and applicable regulations.
• Communicate transparently and effectively, collaborating with both internal and external partners to achieve clinical trial objectives.
• Oversee planning, track study progress, and proactively manage the completion of trial deliverables and milestones.
• Lead and oversee contract research organizations (CROs) and other vendors to ensure contractual obligations are met.
• Ensure accurate trial budget management, timely handling of scope changes, and budget reconciliations.
• Identify and manage risks, propose solutions, oversee contingency planning, and ensure corrective and preventive actions are implemented when necessary.
• Ensure all trial sites and team members, including external partners, receive appropriate trial-specific training for their roles.
• Contribute to or develop trial-related materials, such as the clinical protocol, training materials, instructions for specimen collection, patient information, and consent forms.
• Ensure that vendor systems and processes are configured according to protocol requirements and regulations, and are implemented within the agreed timelines.
• Oversee the availability of investigational products at trial sites and ensure that accurate accountability records are maintained.
• Review monitoring reports, protocol deviations, and data listings to ensure high-quality data is delivered. Monitor data quality, completeness, and timeliness, and address any issues that arise.
• Foster good relationships with trial sites and staff, and oversee patient recruitment.
• Ensure timely collection, documentation, and reporting of adverse events (AEs) and serious adverse events (SAEs), and assist in submitting reports to regulatory authorities.
• Ensure that the Trial Master File (TMF) is kept up to date and well maintained.

• Bachelor's or university degree in a medical or paramedical field (Biology, Biomedical Sciences, Pharmacy, Veterinary Medicine, etc.) or equivalent experience.


• Minimum of 5 years of experience in clinical operations, including trial management, with a track record of managing complex multicenter trials. Experience with infectious diseases, vaccines, and/or controlled human infection model (CHIM) trials is a plus.


• Strong leadership skills with the ability to build effective internal and external working relationships and communicate effectively.


• Excellent organizational skills to manage multiple tasks and prioritize workload.


• Problem-solving skills, with the ability to identify and resolve issues and mitigate risks. Ability to maintain a big-picture view while managing detailed tasks.


• Fluent in English, with strong written and verbal communication skills.


• Knowledge of ICH-GCP and other applicable regulations for the successful conduct of clinical trials.


• Experience with tools and systems for managing clinical trials (CTMS, TMF, IWRS, eCOA, eCRF databases, etc.).