Project Manager

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

📋 Description

• Ensure the effective initiation, planning, execution, monitoring, controlling, and closure of designated clinical research projects.

• Guarantee adherence to study budgets, project scope, timelines, standard operating procedures (SOPs), good clinical practices, regulatory requirements, and study-specific criteria.

• Act as the primary liaison for sponsors, vendors, and internal teams throughout the course of studies.

• Coordinate tasks and deadlines among various departments.

• Supervise project coordinators, Site Start-Up (SSU) team members, Regulatory Document Administrators (RDA), and Regulatory Affairs Coordinators (RAC) involved in site activation activities.

• Manage vendor supplies and services in alignment with site activation timelines.

• Alert the Project Manager II of any at-risk site activation timelines.

• Address sponsor and stakeholder needs and expectations effectively.

• Assist in team training and project resource planning.

• Ensure work quality and deliverables meet standards; provide updates on project status.

• Reconcile study trackers and evaluate discrepancies between planned and actual outcomes.

• Facilitate corrective actions, change control, and risk management processes.

• Review and assist in drafting project operational plans, processes, and manuals.

• Confirm that study documents and deliverables comply with relevant country requirements.

• Oversee site selection, feasibility questionnaires, and the planning of site qualification visits.

• Monitor patient recruitment and subject status; follow up with sites regarding recruitment strategies.

• Participate in Investigator’s Meetings.

• Manage central ethics and regulatory submissions with the Regulatory Affairs team.

• Ensure the collection and maintenance of essential site documents.

• Assist in TMF quality reviews and audits, ensuring inspection readiness.

• Support clinical monitoring activities, including CRA training, visit report assessments, site letters, and handling escalated site issues.

• Track site visits, project-specific training, monitoring reports, follow-up letters, monitoring-plan compliance, and site issue escalations.

• Maintain the project-specific training matrix and verify team training completion.

• Ensure sites possess the necessary study materials and equipment.

• Aid in CRF compliance, query resolution, data review, and database lock timelines in collaboration with Data Management.

• Provide technical, therapeutic, and project management expertise for training and process enhancement.

⛳️ Requirements

• Bachelor of Science in a field related to clinical research.

• Minimum of 3 years of experience in a comparable role, including responsibilities associated with managing clinical studies in the pharmaceutical, biotechnology, and/or CRO sectors.

• At least 2 years of experience coordinating activities related to clinical trial management.

• Comprehensive understanding of GCP and ICH standards, as well as FDA and Canadian regulations.

• Proficient in the Microsoft Office suite.

• Exceptional oral and written communication skills in English; proficiency in French is a plus.

• Strong communication abilities.

• Capacity to work collaboratively in a team environment and foster positive relationships with colleagues and sponsors.

• Adept problem-solving skills.

• Strong organizational capabilities.

• Proven ability to manage multiple projects and work under pressure while adhering to deadlines.

• Experience in managing small to medium-sized projects with a structured approach to project management.

• Demonstrated capability to formulate and implement resource-based project plans.

• Excellent people management skills; experience in working with and leading teams in a matrix structure.

• Candidates must have legal authorization to work in the United States.

🏝️ Benefits

• Engaging work environment.

• Competitive opportunities for advancement.

• Accommodations available throughout the recruitment and selection process for applicants with disabilities, upon request.