Senior Clinical Project Support Specialist - Sponsor dedicated (m/w/d)

IQVIA

Closed

Amsterdam

6 days ago

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Senior Clinical Project Support Specialist - Sponsor dedicated (m/w/d)

Senior Clinical Project Support Specialist needed for sponsor-dedicated role providing operational support for global clinical trials. Requires 5+ years of clinical trial experience and strong knowledge of GCP and ICH guidelines. Position is remote based in the Netherlands, offering a competitive salary starting at €58,500 annually.

RemoteFull-timeSeniorICH-GCPSOPs

Senior Clinical Project Support Specialist - Sponsor dedicated (m/w/d)

Apply

RemoteFull-timeSeniorICH-GCP

Salary

Not specified

Work Location

Amsterdam, North Holland, Netherlands, NL

Work Model

Remote

Experience Required

5 years

Employment Type

Full-time

Experience Level

Not Applicable

Core Qualifications

Technical (Must-have)

ICH-GCPSOPsClinical Trial ManagementTMFISFRegulatory SubmissionsVendor ManagementMS OfficeProject CoordinationBudget ManagementData ManagementStakeholder ManagementRisk ManagementQuality OversightAudit Readiness

Soft Skills

CommunicationOrganizationProblem SolvingIndependencePrioritizationAttention to Detail

Preferred Qualifications

Technical (Nice-to-have)

OMPVeeva

Key Responsibilities

•Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP.
•Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.
•Collaborate with global and regional stakeholders, vendors, and trial teams to ensure seamless trial conduct and communication.
•Manage and maintain clinical trial systems, databases, and tracking tools ensuring data accuracy.
•Prepare and distribute project plans, status updates, reports, and presentation materials.
•Monitor trial progress, budgets, and system data, identifying risks and implementing corrective actions as needed.
•Coordinate documentation workflows, regulatory submissions, and communication with authorities and regional teams.
•Support reporting, trial close-out activities, and preparation of key deliverables (e.g., CTR appendices).
•Coordinate logistics for trial meetings, materials, and supplies.
•Contribute to quality oversight, inspection readiness, and best practices in clinical trial conduct.
•Act as a key point of contact for trial-related systems, documentation, and operational queries.

Clinical ResearchClinical TrialsFSPSponsor DedicatedRemoteSeniorGCPICHNetherlands

Core Qualifications

Technical (Must-have)

Soft Skills

CommunicationOrganizationProblem SolvingIndependencePrioritizationAttention to Detail

Key Responsibilities

•Plan, coordinate, and execute clinical trial activities across regions in compliance with ICH-GCP.

•Maintain and oversee trial documentation (e.g., ISF, TMF, submissions), ensuring completeness, accuracy, timeliness and audit readiness.

•Collaborate with global and regional stakeholders, vendors, and trial teams to ensure seamless trial conduct and communication.

•Manage and maintain clinical trial systems, databases, and tracking tools ensuring data accuracy.

•Prepare and distribute project plans, status updates, reports, and presentation materials.

•Monitor trial progress, budgets, and system data, identifying risks and implementing corrective actions as needed.

•Coordinate documentation workflows, regulatory submissions, and communication with authorities and regional teams.

•Support reporting, trial close-out activities, and preparation of key deliverables (e.g., CTR appendices).

•Coordinate logistics for trial meetings, materials, and supplies.

•Contribute to quality oversight, inspection readiness, and best practices in clinical trial conduct.

•Act as a key point of contact for trial-related systems, documentation, and operational queries.