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, multi-country studies, ensuring conformity with timelines, scope, and sponsor expectations.

• Lead the creation and execution of comprehensive Study Start-Up Plans, addressing regulatory, ethics, and contract execution across all participating nations.

• Steer complete start-up activities from site identification to IP release, ensuring momentum and accountability for critical milestones.

• Offer strategic insights during Bid Defence and Kick-Off meetings, shaping study design and start-up feasibility from the beginning.

• Supervise regulatory and ethics submissions, guaranteeing high-quality, compliant, and timely approvals across different regions.

• Manage site contract and budget negotiations in partnership with legal, finance, and sponsors to facilitate timely site activation.

• Proactively identify risks, dependencies, and bottlenecks, implementing mitigation and escalation strategies to safeguard study timelines.

• Collaborate closely with Project Managers and cross-functional stakeholders to ensure seamless integration of start-up within the overall study delivery.

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

• Lead and coordinate Study Start-Up team members, providing guidance, support, and oversight to ensure consistent delivery.

• Promote process consistency and continuous improvement across regions, contributing to operational excellence initiatives.

• Maintain oversight of study metrics, budgets, and scope of work (SOW), ensuring that delivery remains within agreed parameters.

• Provide clear, structured reporting and updates to sponsors and internal leadership to facilitate informed decision-making.

⛳️ Requirements

• Proven, recent experience in Study Start-Up (SSU) as a primary responsibility, including complete ownership of site activation activities.

• Experience delivering SSU for global or multi-country clinical trials.

• Strong understanding of regulatory and ethics submission processes, including CA/EC and CTA strategy.

• Experience coordinating site contracts and budgets within start-up timelines.

• Demonstrated capability to manage SSU timelines, risks, and competing priorities.

• Practical familiarity with CTMS, eTMF, and clinical trial systems.

• Solid understanding of ICH-GCP and relevant regulatory frameworks.

• Strong stakeholder management and communication skills across sponsors, sites, and internal teams.

• Ability to effectively collaborate across cross-functional, global teams.

• Structured, proactive, and solution-oriented approach to delivery.

🏝️ Benefits

• Various annual leave entitlements.

• A range of health insurance options tailored for you and your family’s needs.

• Competitive retirement planning options to maximize savings and enable confident future planning.

• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to a global network of over 80,000 independent specialized professionals to support your and your family’s well-being.

• Life assurance.

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, and more.