6 days ago

Lead, Trial Delivery Management

Johnson & Johnson

Breda

6 days ago

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Lead, Trial Delivery Management at Johnson & Johnson, responsible for study-level execution, vendor oversight, and country/regional operational delivery across multiple countries. Requires a BS degree, minimum 4 years clinical trial experience, and strong leadership, project management, and communication skills.

RemoteFull-timeMid LevelClinical Trial Management Systems (CTMS)Clinical Research And Regulations

Lead, Trial Delivery Management

Apply

RemoteFull-timeMid LevelClinical Trial Management Systems (CTMS)

Salary

Not specified

Work Location

Breda, North Brabant, Netherlands, NL

Work Model

Remote

Experience Required

4 years

Employment Type

Full-time

Experience Level

Minimum of 4 years clinical trial experience; 2-3 years supporting global clinical trial

Core Qualifications

Technical (Must-have)

Clinical Trial Management Systems (CTMS)Clinical Research and RegulationsClinical Trial DesignsClinical TrialsRegulatory ComplianceQuality Assurance (QA)Standard Operating Procedure (SOP)Project Integration ManagementResearch and DevelopmentResearch EthicsData SavvyLaboratory OperationsProductivity PlanningProfessional Ethics

Soft Skills

LeadershipCommunicationProblem SolvingAnalytical ReasoningDecision-makingMentoringCoachingPresentationOrganizing

Key Responsibilities

•Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).
•Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.
•Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).
•Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.
•Provide input into trial level operational strategies.
•Resolve trial-related issues and mitigate trial-related risks.
•Participate in process improvement activities at a trial, compound & cross-DU level, as needed.
•Provide support 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.

Clinical Trial ManagementPharmaceuticalHealthcareRemoteFull-timeLeadershipVendor OversightRegulatory ComplianceProject ManagementJohnson & Johnson

Core Qualifications

Technical (Must-have)

Soft Skills

LeadershipCommunicationProblem SolvingAnalytical ReasoningDecision-makingMentoringCoachingPresentationOrganizing

Key Responsibilities

•Create and update critical trial-specific documents (e.g., Monitoring Guidelines, Informed Consent Form, Investigational Medicinal Product [IMP] related documentation).

•Manage vendor set up and management of day-to-day study vendor activities, including set-up, SOW creation and budget oversight.

•Responsible for country / regional coordination of trial management activities and oversight (e.g., aligns feasibility strategy with local teams, perform country-level risk reviews, aware of all projects conducted across countries).

•Support development of program-level compound training, collaborating with Clinical / CTL&D / Medical writing.

•Provide input into trial level operational strategies.

•Resolve trial-related issues and mitigate trial-related risks.

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

•Provide support 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.