Project Manager – Feasibility Site Activation

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

📋 Description

• Design and implement Study Start-Up strategies for global and multi-country studies.

• Lead the creation and execution of thorough Study Start-Up Plans that encompass regulatory, ethical, and contractual processes.

• Drive comprehensive start-up activities from site identification to the release of investigational products.

• Provide strategic insights during Bid Defence and Kick-Off meetings.

• Supervise regulatory and ethics submissions across various regions.

• Manage negotiations for site contracts and budgets in collaboration with legal, finance, and sponsors.

• Identify potential risks, dependencies, and bottlenecks, and implement strategies for mitigation and escalation.

• Collaborate with Project Managers and cross-functional teams.

• Ensure the accuracy, quality, and inspection readiness of study documentation, including CTMS and eTMF activities.

• Lead and coordinate the efforts of Study Start-Up team members.

• Promote process consistency and continuous improvement across regions.

• Maintain oversight of study metrics, budgets, and scope of work.

• Provide regular reports and updates to sponsors and internal leadership.

⛳️ Requirements

• Bachelor's degree in Life Sciences or a related discipline.

• Recent experience in Study Start-Up (SSU) with full site activation responsibilities.

• Experience in supporting global and multi-country clinical trials.

• Strong understanding of CA/EC submissions, CTA processes, and regulatory requirements.

• Proven experience in managing site contracts, budgets, and start-up timelines.

• Familiarity with CTMS, eTMF, and other clinical systems.

• Solid grasp of ICH-GCP and relevant regulations.

• Strong skills in stakeholder management, communication, and collaboration.

• Organized, proactive, and solution-focused approach.

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.