Clinical Trial Manager

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

📋 Description

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

• Supervise all clinical trial activities from the initiation phase to the closeout phase.

• 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 the design and development of study materials such as CRFs, patient diaries, study participation cards, and source documents.

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

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

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

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

• Coordinate the provision of study supplies.

• Negotiate contracts with vendors providing clinical trial services.

• Review informed consent forms, CRFs, and other study-related materials.

• Plan and partake in investigator meetings.

• Support the data query process.

• Ensure regulatory compliance of investigational sites with client SOPs, as well as FDA and ICH guidelines.

• Maintain an up-to-date and properly organized trial master file.

• Collaborate with vendors and CROs to facilitate efficient execution of clinical trials.

• Complete necessary training, timesheets, expense reports, and updates to CVs.

• Stay informed about and comply with Parexel processes, ICH-GCPs, and relevant regulations.

• Identify and address issues related to trial execution, manage priorities, and communicate effectively with cross-functional teams, investigators, and stakeholders.

⛳️ Requirements

• Knowledge of Good Clinical Practices (GCPs) and regulatory compliance, including FDA and ICH guidelines.

• Experience in clinical trial documentation and processes, encompassing protocols, CRFs, and monitoring plans.

• Proficiency in data management and query resolution during clinical trials.

• Comprehensive understanding of site management and monitoring procedures.

• A degree in the life sciences field is preferred.

🏝️ Benefits

• Competitive salary and comprehensive benefits package.

• Opportunities for professional growth and development.

• Supportive work environment with a focus on teamwork and collaboration.