Global Clinical Project Manager

PVH (Tommy Hilfiger/Calvin Klein); Paris; Sur place; EUR 90 000 - 150 000; Plein temps

Résumé du poste

Excelya is seeking a Global Clinical Project Manager to lead international Phase I–III studies from protocol through archiving. You will coordinate global teams, manage timelines and budgets, and oversee CROs and vendors to ensure compliant, high‑quality study delivery.

Ideal candidates bring broad Clinical Operations experience, strong leadership, and proven ability to drive study execution in a matrix organization while maintaining inspection readiness and robust TMF quality.

Qualifications

• Degree in Life Sciences or related field.
• Very strong experience in Clinical Operations and as a Global Clinical Trial Manager or equivalent.
• Proven experience leading international Phase I–III clinical trials.
• Strong experience managing CROs and external vendors.
• Solid knowledge of ICH‑GCP, clinical trial regulations, and quality standards.
• Experience with RFP processes and vendor selection.
• Excellent project management, leadership, and stakeholder management skills.

Responsabilités

• Lead and coordinate global study teams to ensure the successful delivery of clinical trials.
• Develop and manage study plans, timelines, budgets, resources, risks, and mitigation strategies.
• Select, manage, and oversee CROs and third‑party vendors, including participation in RFP processes and vendor selection.
• Drive study execution from protocol development through study close‑out and archiving.
• Identify risks, implement corrective actions, and ensure compliance with quality standards and ICH‑GCP requirements.
• Review and contribute to key clinical study documents.
• Facilitate study team meetings and ensure follow‑up of actions and decisions.
• Collaborate with cross‑functional stakeholders to ensure efficient study conduct and patient recruitment strategies.
• Ensure inspection readiness and support audits and regulatory inspections.
• Maintain oversight of Trial Master File (TMF) completeness and study documentation quality.

Connaissances

Global Clinical Trial Manager

Clinical Operations

Project management

Vendor management

ICH-GCP knowledge

RFP processes

Leadership

Formation

Bachelor's degree in Life Sciences

Description du poste

Overview

Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do. As a Global Clinical Project Manager, you will be responsible for leading global clinical study teams and ensuring the successful execution of international Phase I‑III clinical trials from study synopsis to study archiving. You will oversee timelines, budget, quality, CROs, vendors, and cross‑functional teams while ensuring compliance with regulatory requirements and GCP standards.

Key Responsibilities

• Lead and coordinate global study teams to ensure the successful delivery of clinical trials.
• Develop and manage study plans, timelines, budgets, resources, risks, and mitigation strategies.
• Select, manage, and oversee CROs and third‑party vendors, including participation in RFP processes and vendor selection.
• Drive study execution from protocol development through study close‑out and archiving.
• Identify risks, implement corrective actions, and ensure compliance with quality standards and ICH‑GCP requirements.
• Review and contribute to key clinical study documents.
• Facilitate study team meetings and ensure follow‑up of actions and decisions.
• Collaborate with cross‑functional stakeholders to ensure efficient study conduct and patient recruitment strategies.
• Ensure inspection readiness and support audits and regulatory inspections.
• Maintain oversight of Trial Master File (TMF) completeness and study documentation quality.

Qualifications

• Degree in Life Sciences or a related discipline.
• Very strong experience in Clinical Operations and as a Global Clinical Trial Manager or equivalent role.
• Proven experience leading international Phase I‑III clinical trials.
• Strong experience managing CROs and external vendors.
• Solid knowledge of ICH‑GCP, clinical trial regulations, and quality standards.
• Experience with RFP processes and vendor selection.
• Excellent project management, leadership, and stakeholder management skills.
• Ability to work effectively in a matrix organization.