Global Clinical Project Manager

Excelya; Paris; Sur place; EUR 90 000 - 140 000; Plein temps

Résumé du poste

Excelya is seeking a Global Clinical Project Manager to lead international Phase I–III studies from synopsis through archiving, overseeing timelines, budgets, quality, CROs, vendors, and cross‑functional teams while ensuring regulatory compliance and GCP standards.

You will drive study execution, vendor selection, risk management, TMF quality, and patient recruitment strategies, collaborating with stakeholders to maintain inspection readiness in a matrix organization.

Qualifications

• Degree in Life Sciences or related discipline.
• Very strong experience in Clinical Operations and as a Global Clinical Trial Manager or equivalent.
• Proven experience leading international Phase I–III trials.
• Solid knowledge of ICH-GCP, clinical trial regulations, and quality standards.

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.
• Degree in Life Sciences or a related discipline.
• Very strong experience in Clinical Operations and as a Global Clinical Trial Manager or equivalent role.

Connaissances

Global Clinical Trial Manager

Clinical Operations

Vendor & CRO management

Cross-functional leadership

Formation

Degree in Life Sciences or related discipline

Description du poste

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.

• 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.

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here’s what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid‑sized CRO in Europe, while offering the best employee experience.

Our "one‑stop provider" service model—combining full‑service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.