Clinical Trial Manager

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

📋 Description

• The LTM position will be responsible for ensuring high-quality end-to-end trial delivery at the national level.

• Overseeing the uniformity of Local Trial Management duties and processes.

• Act as the primary point of contact for internal partners regarding the study at the country level.

• Manage and supervise Central IRB and other local vendors, including the establishment of vendor purchase orders, invoice review and approval, and change orders as necessary.

• Execute local milestones from feasibility through to study closure.

• Resource country-level roles, including assistance with transitions, in collaboration and agreement with the study Functional Manager (FM).

• Ensure Inspection Readiness and AQR at the national level.

• Collaborate closely with assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to clarify accountabilities and provide necessary support and training.

• Maintain effective communication with Clinical Trial Managers, Clinical Operations, and the Global Trial Leader to ensure trial excellence.

• Conduct country-level ad hoc meetings during any phase of the study to address unforeseen circumstances that may impact country or study deliverables.

• Work in close partnership with the study FM to provide updates, discuss challenges, timelines/resources, and potential risks, and assist with documentation such as storyboards, lessons learned, metrics, etc., as required by leadership.

⛳️ Requirements

• BA/BS degree.

• Degree in a health or science-related field.

• A minimum of 2 years of local trial management experience is required.

• Experience in start-up & Database Locks/Cleaning is preferred.

• Required cross-therapeutic area trial management experience.

• Required oncology trial management experience; Early Development experience is a plus.

• Strong understanding of ICH-GCP, company standard operating procedures, local laws and regulations (e.g., Canadian), REB submissions, assigned protocols, and relevant protocol-specific procedures.

• Proficient IT skills in relevant software and company systems.

• Willingness to travel, including occasional overnight stays, based on business needs.

• Proficient in the country language and English, both spoken and written.

• Strong written and verbal communication skills as appropriate.

• Must be legally authorized to work in Canada and should not require, now or in the future, sponsorship for employment visa status.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellbeing programs including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Opportunities for learning and development through structured training and career pathways.