Clinical Trial Manager

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

📋 Description

• Leads and oversees studies or projects in accordance with the defined scope of work, timelines, and quality benchmarks.

• Aids in formulating a strategy to execute the trial or project in line with protocol and timelines.

• Monitors and evaluates project status to guarantee the successful fulfillment of project parameters, milestones, and schedules.

• Proactively identifies and manages risks associated with trials or projects while collaborating within a cross-functional team.

• Serves as the primary liaison between the Sponsor and Care Access, facilitating the exchange of information between Care Access and the client.

• Appropriately escalates any issues or potential concerns following established escalation pathways; provides timely project updates to upper management and/or Senior Leadership at Care Access.

• Coordinates a cross-functional team to assist in the delivery of the clinical trial.

• Holds teams accountable for the delivery and success of the trial.

• Guides teams to successfully achieve objectives in their respective areas.

• Coordinates activities across all functional departments and vendors involved in the project.

• Collaborates with the team and management to devise plans/guidelines for project implementation utilizing Care Access tools.

• Identifies necessary data and analytics to enable data-driven decisions and continually monitors ongoing project performance.

• Assesses growth opportunities for current or potential engagements; contributes to developing strategies for various initiatives.

• Works with the team to recognize potential risks and formulate contingency plans.

• Plans and communicates specific tasks and priorities for projects to team members.

• Ensures appropriate assessment and coordination of project/protocol-specific and therapeutic area training needs and activities for team members as necessary.

• Maintains project logs and trackers.

• Assists with essential documentation and follow-up of monitoring visits.

• Provides recommendations and alternative solutions to project-specific challenges through established escalation channels.

• Ensures adherence to guidelines and processes for efficient escalation of out-of-parameter issues as required.

• Escalates identified findings from periodic quality reviews and peer feedback reports.

• Collaborates with fellow CTMs and departmental leadership to share best practices.

• Leads the study startup process to support site evaluation and selection visits for each new study, ensuring sites are selected and activated according to study requirements.

• Reviews study information and communicates with key stakeholders across the global organization to address study/site needs, requirements, performance expectations, and timelines.

• Works closely with onsite staff to address inquiries, assess risks, and mitigate issues throughout the startup phase.

• Partners with other Care Access teams to initiate study-related processes at the appropriate SSU milestone (e.g., capacity planning, systems build requests, etc.).

• Collaborates and communicates with the client to drive startup activities, timelines, and expectations of the Care Access startup process.

• Ensures that all information acquired during the startup process is fully transitioned to sites as required.

• Continues to evaluate and enhance study startup processes to improve efficiency and productivity.

• Monitors key performance indicators to track progress and identify areas for improvement.

• Acts as the primary point of contact with the sponsor to facilitate study activation.

⛳️ Requirements

• Requires clinical trial experience.

• Preferred experience in decentralized clinical trials.

• Site experience is preferred, ideally within a site network.

• PMP Certification is preferred.

• A Bachelor's degree is required.

• At least 6+ years of experience in the clinical trial/pharmaceutical industry is necessary.

• A minimum of 4+ years in project management, including client management, is required.

• Must possess 1-2 years of strategy consulting experience.

• Experience overseeing external vendors (e.g., e-consent vendor) is necessary.

• Proven experience in collaborating and leading cross-functional teams in a matrix environment.

• Experience managing multiple projects across various therapeutic areas is essential.

• Ability to anticipate and resolve issues on projects is required.

• Experience in reporting project details to various stakeholders both within and outside the company is necessary.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays

• Options for medical, dental, and vision insurance plans