Senior Project Lead – FSP – Phase IV

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

📋 Description

• Act as the main point of contact between the sponsor and the organization at the project level.

• Ensure that both internal and external escalation procedures are adhered to.

• Outline responsibilities and communication channels for secondary project leads when necessary.

• Take responsibility for the overall delivery of cross-functional projects, including aspects of time, cost, and quality.

• Oversee project-level financial management, which includes understanding contracts, aligning resources, managing out-of-scope activities, negotiating change modifications, and coordinating execution timelines.

• Set, communicate, and manage customer expectations effectively.

• Lead the identification of project-level risks and the resolution of issues through RBQM/RESOLVE.

• Ensure compliance of the project team with organizational policies, SOPs, ICH-GCP, regulatory standards, and specific project requirements.

• Guide cross-functional project teams to achieve or surpass deliverables.

⛳️ Requirements

• A bachelor's degree or an equivalent and relevant formal academic/vocational qualification.

• Prior experience of at least 8 years in a comparable role.

• A minimum of 5 years of experience in Clinical Operations, particularly in managing Phase IV clinical trials.

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

• Capability to delegate tasks and prioritize both personal and project team workloads.

• Strong oral and written communication and presentation abilities.

• A proactive, solutions-focused mindset that adapts to changing priorities.

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

• Robust understanding of project management principles, with a focus on time, quality, cost, and financial insights.

• Excellent interpersonal and customer service skills, including the ability to lead, motivate, and coordinate cross-functional project teams.

• Skills in judgment, decision-making, critical thinking, analytical reasoning, and strategic planning.

• Proficient in negotiating, persuading, and influencing others, with an awareness of cross-cultural dynamics.

• Experience in managing Phase IV studies is mandatory.

• Experience in the biotech sector is advantageous.

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

🏝️ Benefits

• Opportunities for collaboration and professional development.

• Work as part of an international team.

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