Project Manager II, Early Phase

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

📋 Description

• Oversee the initiation, planning, execution, monitoring, control, and closure of assigned Phase I and Phase II clinical trials.

• Serve as the primary point of contact for sponsors, vendors, and internal study teams throughout the lifecycle of the clinical trial.

• Coordinate study resources, deliverables, timelines, budgets, project scope, and clinical operations activities.

• Assist in feasibility assessments, study design, budget creation, progress reporting, and operational planning.

• Maintain open communication with sponsors, study teams, functional departments, clinical sites, and senior management.

• Monitor study budgets, billed time, out-of-scope activities, and manage change orders.

• Lead study start-up tasks including kick-off meetings, TMF setup, site selection and activation, vendor onboarding, site contracting, and budget negotiations.

• Identify and manage risks, enforce quality control measures, and escalate issues as required.

• Facilitate client, internal team, and vendor meetings; document and archive meeting minutes.

• Supervise project deliverables, vendor and subcontractor outputs, and continuous improvement initiatives.

• Maintain study-specific training matrices and verify project training and documentation.

• Review and authorize responses to quality assurance audits.

• Ensure that protocols, informed consent forms, eCRFs, source document templates, TLFs, and clinical study reports are completed on time.

• Oversee TMF filing, maintenance, archiving, completeness, accuracy, and readiness for inspection.

• Monitor recruitment performance and create enrollment mitigation strategies.

• Participate in Investigator Meetings and coordinate ethics submissions with Regulatory Affairs.

• Support study sites by ensuring they have the necessary materials and resources.

• Collaborate with Data Management on CRFs, data review, query resolution, and database locking.

• Partner with Clinical Operations on monitoring activities and adhere to sponsor, SOP, regulatory, GCP, and study requirements.

• Contribute to Clinical Monitoring Plans and provide project-specific CRA training.

• Conduct site initiation visits for single-site studies as needed.

• Develop annotated site visit reports and monitoring tools.

• Mentor junior staff and assist with onboarding processes.

• Offer technical, therapeutic, and project management expertise for departmental training and process improvement.

• Engage in business development activities and contribute to the enhancement of operational tools and processes.

⛳️ Requirements

• A Bachelor's degree (B.Sc.) in a related field to clinical research.

• A minimum of 5 years of experience within the clinical research sector.

• At least 3 years of project management experience in Phase I and Phase II clinical trials.

• Experience in managing multiple clinical trials concurrently across various study sites.

• Previous experience in dermatology clinical trials is strongly preferred.

• In-depth knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, FDA regulations, and relevant local laws.

• Proficient in Microsoft Office Suite.

• Exceptional written and verbal communication skills in English.

• Bilingualism in English and French is highly desirable.

• Ability to work effectively in a collaborative team environment and establish strong relationships with colleagues, sponsors, and other stakeholders.

• Strong problem-solving, critical-thinking, and creative-thinking abilities.

• Solid scientific understanding and knowledge of clinical research.

• Comprehensive understanding of clinical research operations across various functions.

• Capable of managing multiple projects, prioritizing competing demands, and performing well under pressure while meeting deadlines.

• Familiarity with Good Clinical Practices and applicable Health Canada and FDA regulations and guidelines.

• Legally authorized to work in Poland.

🏝️ Benefits

• Permanent full-time position.

• Vacation.

• PPK.

• Health allowance.

• Home-based position with a teleworking allowance.

• Opportunities for ongoing learning and development.

• Attractive advancement opportunities.