Global Clinical Project Manager H/F - Excelya
- Paris - 75
- CDI
- Excelya
Les missions du poste
Excelya is an independent partner that serves Biotech, Pharma, and Medical Device organizations with a comprehensive range of full-service CRO, FSP, and Resourcing solutions guided by our values Energy, Care and Audacity.Founded in 2014 and headquartered in Paris, France, Excelya has a global team of 900+ experts who understand the critical needs of clients to provide bespoke and robust trial solutions across a broad spectrum of therapeutic areas.We take a one-team approach to work: our shared success is the result of collaboration at every stage of a project, from regulatory affairs and clinical operations to quality assurance and strategic development.Excelya is committed to helping our clients deliver life-changing therapies collaboratively, so we can transform tomorrow together.
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.
Le profil recherché
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.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.