Project Manager, Early Phase and Translational Research / Gestionnaire de projet

Description

The Project Manager, EPTR ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned Early Phase clinical research projects. In addition, the Project Manager, EPTR is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables the trials. The Project Manager I, EPTR must ensure compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements. These tasks are done under close supervision by Senior Project Manager/Program Director and/or Director, EPTR.
This role will be perfect for you if:

- We can count on you to deliver results while using a disciplined approach to project management.

- You are looking for the next career step to prepare you to become a project manager.

- You are knowledgeable about clinical research projects and looking to continue learning.

- Working in an organization that is driven by science and innovation and completing meaningful work is important to you.

More specifically, the Project Manager, EPTR:

- May serve as primary contact for the Sponsor, sites, CRAs, vendors and internal team throughout the study. Depending on the scope of the study, may lead the project.

- Coordinates tasks and deadlines between the different departments involved in the project.

- Oversees project coordinators, SSU team members, RDA and RAC resources to ensure correct prioritization of site activation activities amongst team members

- Interacts with vendor management to ensure vendor supplies and services are coordinated for with site activation timelines

- Escalates to project manager when site activation timelines are at risk or cannot be maintained.

- Assists with managing the needs and expectations of the Sponsor and other internal and external project stakeholders.

- Assists with ensuring all team members are adequately trained on the project.

- May plan the activities and resources (e.g. internal and external resources, equipment, etc.) required for the project.

- Manages the quality of assigned work and deliverables

- Assists with providing project status updates to external and internal stakeholders

- Ensures assigned tasks are completed in compliance with the study budget, project scope and timelines and in accordance with applicable standard operating procedures (SOPs), good clinical practices, regulatory and study-specific requirements.

- Reconciles study trackers

- Assists with analyzing discrepancies between planned and actual results and participates in the development and implementation of corrective actions to be taken as needed.

- Assists with enforcing effective change control and risk management throughout the project.

- Reviews and may assist in the drafting of project operational plans, processes, and manuals as applicable (e.g., project management plan, monitoring plan, etc.).

- Assists with ensuring that study specific documents and project deliverables (e.g., protocol, informed consent form, electronic case report form (eCRF), tables/listings/figures (TLFs), clinical study report, etc.) meet applicable country requirements.

- Oversee activities related to sites selection (feasibility questionnaires, sites selection, planning of site qualification visits)

- Monitors patient recruitment, subject status, and follows up with sites on recruitment strategy plan.

- Participates in the planning and conduct of Investigator’s Meeting.

- In collaboration with the Regulatory Affairs group, may oversee activities related to central ethics and regulatory submissions.

- Ensures collection of required essential documents from the sites prior to study initiation and maintains of currency of site level documentation throughout the study.

- May assist the project manager with quality reviews and or audits of the Trial Mas