Project Manager (Spain)

Description

The Project Manager ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned clinical research projects. The Project Manager I 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 Associate Director, Project Management
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.

RESPONSIBILITIES

- May serve as primary contact for the Sponsor, vendors and internal team throughout the study.

- 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 II 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 II 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, visit report review, site letters, and escalated site issues

- May track site qualification, initiation, routine and close-out visits, project-specific training, monitoring