Project Manager (USA)

Indero•Portland, OR

About The Position

The Project Manager ensures the successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects. The Project Manager I ensures compliance with the study budget, project scope, and timelines, and adherence to applicable standard operating procedures (SOPs), good clinical practices, regulatory requirements, and study-specific requirements. The work is performed under close supervision by a Senior Project Manager/Program Director and/or Associate Director, Project Management. The role coordinates study activities and deadlines across departments, supports sponsor and stakeholder needs, oversees site activation activities, and helps manage project resources, quality, risks, changes, and deliverables. It may also include contributions to site selection and recruitment, regulatory and ethics submissions, monitoring, training, Trial Master File readiness, and data review through database lock.

Requirements

B.Sc. in a field related to clinical research.
At least 3 years of experience in a similar role, including clinical study management activities in the pharmaceutical, biotechnology, and/or CRO industry.
At least 2 years of experience coordinating activities related to clinical trial management.
Excellent knowledge of GCP and ICH standards, FDA regulations, and Canadian regulations.
Excellent knowledge of the Microsoft Office suite.
Excellent oral and written English skills.
Excellent communication skills.
Ability to work in a team environment and establish good relationships with colleagues and sponsors.
Good problem-solving abilities and organizational skills.
Strong ability to manage different projects and work under pressure while meeting timelines.
Experience managing small to medium projects using a disciplined project management approach.
Core project management competencies.
Demonstrated ability to establish and deliver resource-based project plans.
Excellent people management skills and experience working with and managing teams in a matrix environment.

Nice To Haves

French language skills.

Responsibilities

May serve as the primary contact for the Sponsor, vendors, and internal team throughout the study.
Coordinate tasks and deadlines among the different departments involved in the project.
Oversee project coordinators, SSU team members, RDA, and RAC resources to ensure appropriate prioritization of site activation activities.
Coordinate with vendor management to align vendor supplies and services with site activation timelines.
Escalate site activation timeline risks or delays to Project Manager II.
Assist with managing the needs and expectations of the Sponsor and other internal and external stakeholders.
Assist in ensuring that all team members are adequately trained on the project.
May plan project activities and required resources, including internal and external resources and equipment.
Manage the quality of assigned work and deliverables.
Assist with providing project status updates to internal and external stakeholders.
Ensure assigned tasks comply with the study budget, project scope, timelines, applicable SOPs, good clinical practices, regulatory requirements, and study-specific requirements.
Reconcile study trackers.
Assist in analyzing discrepancies between planned and actual results and participate in developing and implementing corrective actions.
Assist in enforcing effective change control and risk management throughout the project.
Review and may assist in drafting project operational plans, processes, and manuals, such as project management and monitoring plans.
Assist in ensuring study documents and project deliverables meet applicable country requirements.
Oversee site selection activities, including feasibility questionnaires, site selection, and planning site qualification visits.
Monitor patient recruitment and subject status, and follow up with sites on recruitment strategy plans.
Participate in planning and conducting Investigator’s Meetings.
In collaboration with Regulatory Affairs, may oversee central ethics and regulatory submissions.
Ensure required essential documents are collected from sites before study initiation and that site-level documentation remains current throughout the study.
May assist Project Manager II with Trial Master File quality reviews or audits to ensure inspection readiness.
May support clinical monitoring activities, including 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 visit reports and follow-up letters; monitoring-plan compliance; and escalated site issues.
Maintain the project-specific training matrix and confirm team members are trained according to the study matrix before performing study tasks.
Support sites and ensure they have materials needed to conduct the study, such as investigational product, study supplies, special equipment, and safety lab kits.
In collaboration with Data Management, may help ensure the CRF complies with the protocol and Sponsor requirements, and that queries and data review are completed to study timelines through database lock.
May provide technical, therapeutic, and project management expertise in departmental training and process improvement efforts.