Country Clinical Project Lead

IQVIA Inc; Lisboa; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

IQVIA Inc in Lisbon, Portugal, seeks a Local Clinical Project Manager to lead country-level study teams and ensure timely delivery of clinical data compliant with ICH-GCP and local regulations.

The role involves site selection, qualification, feasibility assessments, regulatory submissions, and maintaining study documentation in CTMS, with travel as required. Strong leadership in cross-functional teams and Oncology knowledge is essential.

Qualifikationen

• Bachelor degree in related discipline; life sciences preferred.
• At least a year of experience in Clinical Project Management at Local level.
• Excellent understanding of the Clinical Study Process including monitoring.

Aufgaben

• Has overall responsibility for study commitments within the country and timely data delivery of required quality.
• Leads Local Study Team consisting of CRA/CSA; ensures compliance with Sponsor SOPs, ICH-GCP and local regulations.
• Coordinates site selection, Site Qualification Visits, and feasibility assessments.
• Ensures timely preparation and submission of documents to EC/IRB and regulatory authorities for the study duration.
• Prepares country Master CSA, site budgets, MICF translations, and essential study documents at country/site level.
• Sets up and maintains the study in CTMS and local websites; oversees monitoring from activation to closure.

Kenntnisse

Leadership

Project management

Oncology knowledge

Cross-functional teamwork

Portuguese (PT)

English

Monitoring

Regulatory understanding

Travel flexibility

Ausbildung

Bachelor degree

Tools

CTMS

Regulatory submissions tools

Jobbeschreibung

IQVIA Inc in Lisbon, Portugal, seeks a Local Clinical Project Manager to lead country-level study teams and ensure timely delivery of clinical data compliant with ICH-GCP and local regulations.

The role involves site selection, qualification, feasibility assessments, regulatory submissions, and maintaining study documentation in CTMS, with travel as required. Strong leadership in cross-functional teams and Oncology knowledge is essential.