Project Manager II

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

📋 Description

• Assume complete responsibility for the effective initiation, planning, execution, monitoring, controlling, and closure of designated clinical trials.

• Supervise and coordinate study resources while ensuring compliance with budgets, scope, timelines, SOPs, GCP, regulatory standards, and study-specific requirements.

• Serve as the primary communication link to relevant stakeholders.

• Contribute insights for feasibility assessments, study design, and budget formulation.

• Ensure regular progress reports on resources, budget, and timelines.

• Act as the principal contact for the Sponsor, providing timely updates on trial progress.

• Lead client conference calls.

• Oversee and engage in the preparation of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

• Participate in the planning and execution of Investigator’s Meetings.

• Ensure that sites possess the necessary investigational products, study supplies, equipment, and safety lab kits.

• Spearhead study initiation activities, including trial kick-off, TMF setup, site selection and activation, vendor setup, contracting, and budgeting.

• Collaborate with Regulatory Affairs on submissions and essential documentation.

• Work in partnership with Data Management on CRF alignment, data reviews, query resolution, and database-lock timelines.

• Maintain studies in an audit-ready state and monitor the quality of study deliverables.

• Manage risks, control measures, and quality-related issues.

• Analyze discrepancies between planned and actual outcomes.

• Review and approve responses to quality assurance audits.

• Oversee project budgets and identify out-of-scope activities requiring change orders.

• Manage trial timelines, budgets, resources, and vendors.

• Coordinate tasks and deliverables across various functional departments.

• Communicate effectively with study teams, functional departments, and senior management.

• Manage and report on recruitment status and initiatives.

• Lead the core project team and ensure comprehensive project training.

• Coordinate with vendors and teams in Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, and Scientific Affairs.

• Maintain the project-specific training matrix and training records.

⛳️ Requirements

• B.Sc. in a field related to clinical research.

• A minimum of 5 years of experience in the industry.

• At least 3 years of experience in project management for Phase I-III clinical trials.

• Experience in managing dermatology and/or rheumatology trials.

• Proven experience leading concurrent multi-center clinical trials with budgets exceeding $3M USD.

• Strong knowledge of GCP and ICH guidelines.

• Comprehensive understanding of FDA and Canadian regulations.

• Proficient in Microsoft Office suite.

• Excellent verbal and written communication skills in English.

• Ability to work collaboratively within a team and build strong relationships with colleagues and sponsors.

• Effective problem-solving skills.

• Strong organizational capabilities.

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

• Legally authorized to work in Poland.

🏝️ Benefits

• Permanent full-time employment.

• Vacation benefits.

• PPK (Employee Pension Scheme).

• Health allowance.

• Home-based position with a teleworking allowance.

• Opportunities for ongoing learning and professional development.

• Attractive prospects for career advancement.

• Recruitment accommodations for applicants with disabilities, available upon request.