Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.
As a Study Team Leader (STL), 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.
Requirements
- 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.
Benefits
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Here’s what makes us unique.
We are a young, ambitious health company representing 900 Excelyates, driven to become Europe’s leading mid-size CRO with the best employee experience. Our one-stop provider service model offering full-service, functional service provider, and consulting enables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patient’s journey.
Excelling with care means benefiting from an environment that values your natural talents, pushes boundaries with audacity, and nurtures your potential, allowing you to contribute fully to our shared mission.
Skills Required
- 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.
What We Do
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 compassion, care, and excellence. Founded in 2014 and headquartered in Paris, France, and operating in 28 countries across Europe, USA and India, 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, with speciality focus on Oncology & Hematology, Rare Disease & Pediatrics, Infectious Disease, Inflammation & Immunotherapy, Pain Treatment & CNS, and Late Phase & RWE.
