Local Study Project Manager – Sponsor Dedicated

IQVIA

. Lead Local Study Teams consisting of CRAs and Study Start Up Specialists for assigned studies.

Posted 10/27/2026full-timeDublin • IrelandSeniorLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading Local Study Teams and managing clinical trial processes, including regulatory compliance, study financial management, and risk resolution. Proficient in applying GCP and ICH guidelines while ensuring effective communication and collaboration across teams.

Highest-signal resume keywords

Clinical Trial ManagementRegulatory ComplianceOncology KnowledgePhase III Study ExperienceGCP and ICH Guidelines Application

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory SubmissionStudy Financial ManagementTechnical WritingRisk AssessmentSite MonitoringDrug Development ProcessFeasibility AssessmentProject PlanningStudy Coordination

Soft Skills

Negotiation SkillsCommunication SkillsInterpersonal SkillsTeam CollaborationProblem-Solving

Tools & Technologies

TMF SystemsRegulatory DatabasesTracking ToolsStudy Management Systems

Industry Keywords

Clinical ResearchOncologyGCPICHPhase III StudiesRegulatory GuidelinesDrug DevelopmentClinical Environment

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead Local Study Teams consisting of CRAs and Study Start Up Specialists for assigned studies.
Coordinate clinical and operational feasibility assessments and the site selection process.
Plan and coordinate local drug activities, from local purchase or reimbursement through drug destruction.
Set up and maintain studies in applicable systems and local websites according to local laws and regulations.
Oversee monitoring activities from site activation through study closure at country and site level.
Identify risks and facilitate resolution of complex study problems and issues.
Organize regular agenda-driven Local Study Team meetings.
Report study progress and updates to the Global Study Associate Director/Global Study Team.
Assist with forecasting study timelines, resources, recruitment, budget, study materials, and drug supplies.
Ensure country-level regulatory submission systems, databases, tracking tools, timelines, and project plans are accurate and maintained.
Ensure accurate study-related payments according to local regulations and agreements.
Train and coach new Local Study Team members on ICG-GCP and IQVIA or Sponsor Procedural Documents.
Maintain complete TMF systems and timely uploading of essential documents to preserve inspection-ready status.
Plan and lead audit and regulatory inspection activities with Quality Assurance.
Oversee Site Activation and/or Maintenance in accordance with the agreed Start Up strategy and timelines.
Ensure collaboration across Regulatory and Start Up & Site Activation teams, regions, and countries.
Provide specialist regulatory and technical scientific support to the Start Up team.
Determine regulatory strategy, expectations, submission parameters, and required authorizations.
Assess regulatory landscapes and contribute to regulatory intelligence collection, analysis, interpretation, and dissemination.

Requirements

What you’ll need

Bachelor's Degree Life sciences or related field.
7 years’ relevant experience in a scientific or clinical environment; equivalent combination of education, training and experience.
Knowledge of Oncology therapeutical area.
Proven work experience in Phase III studies.
Strong negotiation and communication skills with ability to challenge.
Excellent interpersonal skills and strong team player.
Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projects.
Thorough understanding of regulated clinical trial environment and in-depth knowledge of drug development process, including site monitoring experience.
Demonstrated proficiency in using systems and technology to achieve work objectives.
Good regulatory and technical writing skills.
Strong knowledge and ability to apply Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines and applicable regulatory guidelines.
Excellent understanding of study financial management.
Proven ability to work on multiple projects balancing competing priorities.
Very good knowledge of English language.
Willingness to travel occasionally.
Candidates must be based in one of the listed locations: Dublin, Ireland; Belgrade, Serbia; London, United Kingdom; Kyiv, Ukraine; Reading, Berkshire, United Kingdom; Zagreb, Croatia; or Sofia, Bulgaria.
This role is not eligible for UK visa sponsorship.

Benefits

Comp & perks

Full-time employment
Occasional travel opportunity