Regional Clinical Study Lead - Site Activation & Oversight

IQVIA; Dublin; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

IQVIA is seeking a Local Study Project Manager to lead Local Study Teams and ensure site activation, initiation and regulatory submissions for country-level studies. You will oversee budgets, timelines and quality across multiple sites, coordinating with regulators, sponsors and regional teams.

The role requires oncology knowledge, Phase III experience, strong communication and a willingness to travel occasionally to ensure successful study delivery in Ireland.

Qualifications

• Bachelor's Degree in Life sciences or related field.
• 7+ years of relevant experience in a scientific or clinical environment.
• Strong knowledge of Oncology therapeutical area.
• Proven work experience in Phase III studies.
• Excellent negotiation and communication skills.
• Strong interpersonal skills and team player mindset.
• Proven ability to manage multiple projects with quality and timelines.
• Good regulatory and technical writing skills.
• Solid understanding of GCP/ICH guidelines and regulatory requirements.
• Strong study financial management knowledge.
• Willingness to travel occasionally.

Responsabilités

• Leads Local Study Team of CRAs and Start Up Specialists for assigned studies.
• Coordinates site selection with stakeholders and plans local drug activities.
• Sets up and maintains study in systems and local websites per local laws.
• Oversees monitoring activities from site activation through study closure.
• Identifies risks and facilitates resolution of complex study problems.
• Organizes Local Study Team meetings and reports progress to directors.
• Assists in forecasting timelines, resources, budgets, materials and drug supplies.
• Ensures compliance of TMF and essential documents for inspection readiness.
• Plans and leads audits and regulatory inspections with QA.
• Ensures collaboration across Regulatory, Start Up and Site Activation across regions.

Connaissances

Project leadership

Regulatory knowledge

Clinical operations

Stakeholder management

Budget management

Communication

Team coordination

Formation

Bachelor's Degree Life sciences

Description du poste

IQVIA is seeking a Local Study Project Manager to lead Local Study Teams and ensure site activation, initiation and regulatory submissions for country-level studies. You will oversee budgets, timelines and quality across multiple sites, coordinating with regulators, sponsors and regional teams.

The role requires oncology knowledge, Phase III experience, strong communication and a willingness to travel occasionally to ensure successful study delivery in Ireland.