1 day ago

Senior Manager, Trial Delivery Leader (1 of 7)

Johnson & Johnson

Leiden

1 day ago

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Johnson & Johnson is seeking a Senior Manager, Trial Delivery Leader for its Oncology team to lead clinical trial delivery across multiple countries (Belgium, Netherlands, Poland, Switzerland, UK) in a hybrid work model. The role requires a Bachelor's degree, at least 8 years in pharmaceutical/healthcare, and 2+ years leading global clinical trials, with strong leadership and project management skills.

HybridFull-timeDirectorClinical Trial ManagementGlobal Clinical Studies

Senior Manager, Trial Delivery Leader (1 of 7)

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HybridFull-timeDirectorClinical Trial Management

Salary

Not specified

Work Location

Leiden, South Holland, Netherlands, NL

Work Model

Hybrid

Experience Required

8 years

Employment Type

Full-time

Experience Level

Senior Manager

Core Qualifications

Technical (Must-have)

Clinical Trial ManagementGlobal Clinical StudiesProject PlanningTeam MentorshipPharmaceutical Development ProcessClinical ResearchRisk ManagementBudget ManagementComplianceHealth Authority InspectionsQA AuditsProcess ImprovementMentoringCoachingPresentation Skills

Soft Skills

LeadershipDecision-makingAnalyticalFinancial ManagementCommunicationTeam ProductivityCohesivenessMentoringCoachingEmployee EngagementInclusion

Preferred Qualifications

Technical (Nice-to-have)

BudgetingClinical Trial DesignsClinical TrialsCompliance ManagementConsultingContract ManagementExecution FocusFact-Based Decision MakingGive FeedbackIndustry AnalysisLaboratory OperationsOrganizingProcess ImprovementsProject Integration ManagementResearch and DevelopmentResearch EthicsTechnical Credibility

Key Responsibilities

•Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.
•Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).
•Proactively ensure that trial deliverables and milestones are met.
•Identify risks and ensure mitigation and contingencies are being initiated and followed through.
•Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.
•Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.
•Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.
•Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.
•Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
•Lead and ensure inspection readiness for program through risk identification and readiness review.
•Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.
•Mentor & support onboarding of new team members, particularly those in Trial Management.
•Foster employee engagement, inclusion, and Credo Behaviours.

Clinical Trial ManagementOncologyPharmaceuticalSenior ManagerHybridHealthcareR&D OperationsProject ManagementGlobal Clinical StudiesLeadership

Core Qualifications

Technical (Must-have)

Soft Skills

LeadershipDecision-makingAnalyticalFinancial ManagementCommunicationTeam ProductivityCohesivenessMentoringCoachingEmployee EngagementInclusion

Preferred Qualifications

Technical (Nice-to-have)

Key Responsibilities

•Lead the Cross Functional Trial Team (CFTT) to influence and execute delivery of the operational plan and for end-to-end trial execution.

•Accountable for overall trial delivery, budget, timelines, quality, and milestones (e.g., support DBL / CSR / TLR planning and scope, define protocol deviations and resolution pathways).

•Proactively ensure that trial deliverables and milestones are met.

•Identify risks and ensure mitigation and contingencies are being initiated and followed through.

•Ensure trial is operationalized in compliance with global health authority regulations and guidelines and internal operating procedures and processes.

•Accountable for identifying risks in study conduct, developing mitigation plans and escalating concerns to the CT or CDT.

•Participate in preparation for, and conduct of, Health Authority inspections and internal QA audits.

•Ensure that the trial team operates in a constant state of inspection-readiness, collaborating with R&D Quality to ensure quality oversight.

•Participate in process improvement activities at a trial, compound & cross-DU level, as needed.

•Lead and ensure inspection readiness for program through risk identification and readiness review.

•Provide leadership during Health Authority inspections and on the identification of risks and mitigation plans at the program level for key issues.

•Mentor & support onboarding of new team members, particularly those in Trial Management.

•Foster employee engagement, inclusion, and Credo Behaviours.