Associate Project Manager, Early Phase

The Associate Project Manager, Early Phase and Translational Research (APM, EPTR) ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned Early Phase clinical research projects. In addition, the APM, EPTR is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables the trials. The APM, 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.

RESPONSIBILITIES

More specifically, the Associate 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)
- 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 Master File (TMF) to ensure inspection readiness.
- May support clinical monitoring activities, such as CRA training, development of annotated site visit reports and monitoring tools, perform visit report review, site letters, and identification of quality issues and trends related to site performance and clinical monitoring activities.
- May serve as a point of contact for CRAs and Lead CRAs for assigned projects.
- May track site qualification, initiation, routine and close-out visits, project-specific training, monitoring visit reports and follow-up letters, compliance with monitoring plan, escalation of site-related issues.
- Maintains the project specific training matrix and confirms project team members are fully training per the study matrix prior to team members performing study tasks
- Supports the sites and ensures that each site has the necessary material to adequately perform the study (e.g., investigational product, study supplies, special equipment, safety lab kits, etc.).
- In collaboration with the Data Management group, may ensure that the CRF complies with the protocol and Sponsor requirements and ensures queries resolution and data review process follow the study timelines until database lock.
- Support development of study-specific trackers and sites and Sponsors dashboards in Smartsheet.
- May provide technical, therapeutic and project management expertise in training and process improvement efforts for the department.

The APM, EPTR may also assume the following responsibilities