Project Manager – Europe

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

📋 Description

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

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

• Act as the primary liaison for sponsors, vendors, and internal teams throughout the research process.

• Coordinate tasks and deadlines across various departments.

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

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

• Raise any risks to site activation timelines to the Project Manager II.

• Address the needs and expectations of sponsors and stakeholders.

• Organize project activities and allocate resources effectively.

• Oversee the quality of assigned work and deliverables.

• Provide project status updates to both internal and external stakeholders.

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

• Engage in corrective actions, change control, and risk management processes.

• Review and assist in the creation of project operational plans, processes, and manuals.

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

• Manage site selection and site qualification procedures.

• Monitor patient recruitment and subject status, following up with sites regarding 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 quality reviews and audits of the Trial Master File.

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

• Track all site qualification, initiation, routine and close-out visits, training, monitoring reports, follow-up letters, and site issue escalations.

• Maintain the project-specific training matrix and verify team training completion before study tasks commence.

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

• Collaborate with Data Management to ensure CRF compliance, resolve queries, and review data until database lock.

• Offer technical, therapeutic, and project management expertise in training and process enhancement.

⛳️ Requirements

• B.Sc. in a relevant field associated with clinical research.

• A minimum of 3 years of experience in a comparable role, including management of clinical studies in the pharmaceutical, biotechnology, and/or CRO sectors.

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

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

• Proficient in the Microsoft Office suite.

• Strong oral and written communication skills in English; knowledge of French is an advantage.

• Excellent communication abilities.

• Capability to work collaboratively in a team environment and foster good relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Good organizational capabilities.

• Ability to manage multiple projects and work effectively under pressure while meeting deadlines.

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

• Proven capability to establish and implement resource-based project plans.

• Exceptional people management skills; experience in working with and leading teams in a matrix environment.

• Must have legal authorization to work in the EU.

🏝️ Benefits

• Permanent full-time position.

• Flexible working schedule.

• Vacation leave.

• Home-based work opportunity.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.

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