Senior Project Manager – FSP

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

📋 Description

• Act as the primary Project Lead embedded with the client and main point of contact for sponsors.

• Take ownership of the overall project delivery concerning quality, timelines, and budget.

• Set and communicate customer expectations to the project team effectively.

• Direct cross-functional project teams and manage projects of increasing complexity.

• Coordinate study teams, stakeholders, and CRO/Vendor relations.

• Execute clinical studies from start to finish while adhering to sponsor processes, tools, and performance metrics.

• Supervise study timelines, budgets, CRO/vendor deliverables, out-of-scope activities, and contract adjustments.

• Lead risk management efforts, including mitigation, issue escalation, and resolution.

• Manage complex rescue/transition studies, encompassing transition planning, financial oversight, reconciliation, risk identification, and cross-functional coordination.

• Provide ICF Project Management within Medical Writing, supervising the development of global informed consent forms and the implementation of protocol amendments.

• Oversee sponsor reviews, country customizations, translation readiness, and expedited delivery timelines.

• Ensure compliance with regulatory requirements and ICH-GCP standards while maintaining communication among study teams, sponsors, and stakeholders.

⛳️ Requirements

• Bachelor's degree or an equivalent and relevant academic/vocational qualification.

• 8+ years of pertinent experience.

• Experience in the biotech sector is advantageous.

• Background in rare diseases, auto-immune conditions, and/or oncology clinical trials is a plus.

• Proficient in technical and systems tools, including Microsoft Outlook, Word, Excel, PowerPoint, MS Project, CTMS, TMF, IWRS, eCOA, and eCRF databases.

• Ability to delegate tasks and prioritize workload and resources in a dynamic environment.

• Strong oral and written communication and presentation abilities.

• Comprehensive knowledge of therapeutic areas and clinical development guidelines and directives.

• Advanced understanding of cross-functional project management principles concerning time, quality, and cost.

• Capability to lead, inspire, and coordinate cross-functional project teams.

• Exceptional customer service, negotiation, financial acumen, judgment, critical thinking, and strategic thinking skills.

• Proven ability to work independently with minimal supervision.

🏝️ Benefits

• Opportunities for collaboration and professional development.

• An environment that fosters passion, innovation, and scientific excellence.