Senior Project Manager – Dermatology/Rheumatology

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

📋 Description

• Act as the main point of contact for the Sponsor.

• Deliver prompt and effective updates regarding trial progress.

• Facilitate client calls.

• Supervise and actively engage in the development of study plans, protocols, informed consent forms, eCRFs, TLFs, and clinical study reports.

• Take part in the planning and execution of Investigator Meetings.

• Ensure that sites are equipped with necessary materials, including investigational products, study supplies, specialized equipment, and safety lab kits.

• Maintain assigned studies in an audit-ready state.

• Monitor the quality of study deliverables from vendors and SubCROs, addressing any issues that arise.

• Manage risks and implement control measures to ensure project quality.

• Analyze inconsistencies between planned and actual results.

• Review and endorse responses to quality assurance audits.

• Oversee project budgets, including internal hours allocated to various activities.

• Identify activities that fall outside the scope for change orders.

• Manage trial timelines, budgets, resources, and vendor relationships.

• Coordinate tasks and deliverables across various functional departments.

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

• Oversee and report on recruitment status, identifying initiatives necessary to meet recruitment timelines.

• Lead the core project team, which includes Associate Project Managers, Project Coordinators, and Project Assistants.

• Ensure that team members receive sufficient project training.

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

⛳️ Requirements

• Bachelor's degree in a field related to clinical research.

• Minimum of 10 years of industry experience, including at least 3 years in a CRO.

• At least 7 years of experience in global clinical project management.

• Proven experience managing all phases of projects from initiation to closure.

• Experience overseeing all functional services and vendor management.

• Background in managing mid-size and large studies across more than 10–15 countries and multiple regions (NA, SA, APAC, MENA, Europe).

• Experience leading multicentered, multinational Phase III clinical trials.

• Proficient in project budget financial tracking and forecasting.

• PMP or PRINCE2 certification is a plus.

• Therapeutic experience in dermatology, onco-dermatology, rheumatoid arthritis, or oncology trials is advantageous.

• Familiarity with GCP and ICH standards as well as local country regulations.

• Strong proficiency in the Microsoft Office suite.

• Fluency in English with excellent oral and written communication skills is essential.

• Bilingualism in English and the local language is a beneficial asset.

• Ability to thrive in a team-oriented environment and build positive relationships with colleagues and sponsors.

• Strong problem-solving skills.

• Capability to manage multiple projects and perform under pressure while adhering to timelines.

• Must be legally authorized to work in Poland.

🏝️ Benefits

• Permanent full-time employment.

• Paid vacation.

• PPK (Employee Capital Plans).

• Health allowance.

• Home-based position with a teleworking allowance.

• Continuous learning and development opportunities.

• Attractive potential for career advancement.

• Disability accommodations available throughout the recruitment and selection process upon request.