Senior Project Lead – FSP – Phase IV

Thermo Fisher Scientific

. Serve as the primary contact between the sponsor and the organization at the project level .

Posted 11/9/2026full-timeRemote • BelgiumSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Clinical Operations and Project Management, with a strong focus on Phase IV study management, financial stewardship, and compliance with regulatory requirements. Proven ability to lead cross-functional teams, manage customer expectations, and drive project delivery within time, cost, and quality parameters.

Highest-signal resume keywords

Clinical Trial ManagementProject Management PrinciplesFinancial StewardshipRegulatory ComplianceCross-Functional Team Leadership

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical OperationsPhase IV Study ManagementFinancial AcumenProject DeliveryRisk IdentificationChange Modification NegotiationsTechnical CompetencyAnalytical ThinkingStrategic ThinkingCommunication Pathways

Soft Skills

Effective CommunicationInterpersonal SkillsJudgmentDecision-MakingAdaptability

Tools & Technologies

Microsoft OutlookMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMS ProjectCTMSTMFIWRSECOAECRF

Certifications & Qualifications

Bachelor's DegreeRelevant Formal Academic Qualification

Industry Keywords

Biotech ExperienceRare DiseaseAuto-ImmuneOncology Clinical TrialsICH-GCP

About the role

Key responsibilities & impact

Serve as the primary contact between the sponsor and the organization at the project level
Ensure internal and external escalation pathways are followed
Define responsibilities and communication pathways for secondary project leads when required
Be accountable for overall cross-functional project delivery, including time, cost, and quality
Manage project-level financial stewardship, including contract understanding, resource alignment, out-of-scope activity, change modification negotiations, and execution timelines
Establish, communicate, and manage customer expectations
Drive project-level risk identification and issue resolution through RBQM/RESOLVE
Ensure project team compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific requirements
Lead cross-functional project teams to meet or exceed deliverables

Requirements

What you’ll need

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience comparable to 8+ years
Minimum of 5 years of experience in Clinical Operations, including clinical trial management of Phase IV studies
Technical and systems competency, including Microsoft Outlook, Word, Excel, PowerPoint, MS Project, CTMS, TMF, IWRS, eCOA, eCRF databases, and AI technology
Ability to delegate and prioritize own and project team members' workload
Effective oral and written communication and presentation skills
Proactive, solutions-oriented, and adaptable to changing priorities
Advanced therapeutic area knowledge and clinical development guidelines and directives
Strong understanding of project management principles, including time, quality, cost, and financial acumen
Interpersonal and customer service skills, including leading, motivating, and coordinating cross-functional project teams
Judgment, decision-making, critical thinking, analytical thinking, and strategic thinking skills
Ability to negotiate, persuade, and influence others, including cross-cultural awareness
Phase IV study management experience is required
Biotech experience is a plus
Rare disease, auto-immune, and/or oncology clinical trial background is a plus

Benefits

Comp & perks

Collaboration and development opportunities
Work as part of a global team
Environment valuing passion, innovation, and scientific excellence