Oncology Local Study Project Lead – Phase III

IQVIA Inc

Dublin

On-site

EUR 90,000 - 130,000

Full time

6 days ago

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Job summary

IQVIA is seeking a Local Study Project Manager to lead country-level Local Study Teams for clinical studies, ensuring activation and ongoing regulatory compliance. You will coordinate site selection, budgeting and monitoring activities, while ensuring documentation and TMF readiness.

The role requires Oncology focus and Phase III experience. Applicants should have strong leadership and negotiation skills, an in-depth understanding of GCP/ICH guidelines, and excellent English language

Qualifications

7 years’ relevant experience in a scientific or clinical environment.
Oncology therapeutical area.
Proven work experience in Phase III studies.
Strong negotiation and communication skills.
Excellent interpersonal skills and strong team player.
Understanding of regulated clinical trial environment and drug development process.
Good regulatory and technical writing skills.
Strong knowledge of English language.

Responsibilities

Leads Local Study Team consisting of CRAs and Study Start Up Specialists for assigned studies, ensuring feasibility and quality.
Coordinates the site selection process with relevant stakeholders.
Plans and coordinates local drug activities and budget
Sets up and maintains the study in systems at country level and local websites where required by local laws.
Oversees monitoring activities from site activation to study closure.
Identifies risks and facilitates resolution of complex study problems.