Local Clinical Project Lead – Oncology Studies

IQVIA

Oeiras

On-site

EUR 55,000 - 90,000

Full time

23 hours ago

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Job summary

IQVIA is seeking a Local Clinical Project Manager to lead country-level study teams and ensure timely, quality data delivery in compliance with ICH-GCP and local regulations. The role may involve site monitoring and ensuring site qualification, set up, initiation, and archiving of essential documents.

You will coordinate cross-functional teams including CRAs and CSAs, manage country budgets, and work with Regulatory Affairs for submissions.

Qualifications

Bachelor degree in life science or equivalent.

Responsibilities

Overall responsibility for study commitments within the country and timely data delivery.
Leads Local Study Team of CRA/CSA for assigned studies.
Ensure compliance with Sponsor Procedural Documents, ICH-GCP and local regulations.
Coordinate site selection by identifying potential sites and performing Site Qualification Visits.
Submit documents to EC/IRB at start-up and during the study.
Prepare country Master CSA and study budget amendments.
Set up and maintain CTMS at country level and local websites.
Oversee monitoring activities from activation to study closure.
Review monitoring visit reports and advise monitors.
Identify risks and drive issue resolution.
Organize regular Local Study Team meetings.