Project Manager

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

📋 Description

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

• Guarantee adherence to study budgets, project scope, timelines, SOPs, good clinical practices, regulatory standards, and study-specific requirements.

• Act as the primary liaison for sponsors, vendors, and internal teams throughout the study lifecycle.

• Coordinate tasks and deadlines among departments involved in the project.

• Supervise project coordinators, SSU team members, RDA, and RAC resources, prioritizing site activation activities.

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

• Escalate site activation risks to the Project Manager II.

• Manage the needs and expectations of sponsors and stakeholders.

• Ensure that team members receive adequate training on the project.

• Plan project activities and allocate resources effectively.

• Oversee the quality of assigned work and deliverables.

• Provide project status updates to stakeholders.

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

• Participate in corrective actions, change control, and risk management activities.

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

• Ensure that study documents and deliverables comply with applicable country requirements.

• Oversee site selection and qualification activities.

• Monitor patient recruitment and follow up with sites on recruitment strategies.

• Participate in Investigator’s Meetings.

• Oversee central ethics and regulatory submissions in collaboration with Regulatory Affairs.

• Ensure the collection and maintenance of essential site documents.

• Assist with TMF quality reviews and audits to ensure inspection readiness.

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

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

• Maintain the project-specific training matrix.

• Provide support to sites regarding investigational products, study supplies, equipment, and safety lab kits.

• Ensure CRFs comply with protocol and sponsor requirements, facilitating query resolution and data review through database lock.

• Provide technical, therapeutic, and project management expertise to enhance training and process improvement.

⛳️ Requirements

• B.Sc. in a related field of study relevant to clinical research.

• Minimum of 3 years of experience in a similar role, including managing clinical studies within the pharmaceutical, biotechnology, and/or CRO sectors.

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

• Strong knowledge of GCP and ICH standards, as well as FDA and Canadian regulations.

• Proficient in Microsoft Office suite.

• Exceptional oral and written communication skills in English.

• Proficiency in French is a plus.

• Excellent interpersonal communication abilities.

• Capacity to work collaboratively in a team environment and build strong relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Solid organizational abilities.

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

• Experience handling small to medium projects with a disciplined project management approach.

• Demonstrated skill in establishing and delivering resource-based project plans.

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

• Must have legal authorization to work in Poland.

🏝️ Benefits

• Permanent full-time position.

• Vacation time.

• PPK (Employee Capital Plans).

• Health allowance.

• Home-based position with teleworking allowance.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.