About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Medical Affairs. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

As an Entry level Epidemiologist, you will support ongoing projects you will be involved in:

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

About the Job

Join Excelya as a CMC Specialist and become an integral part of a dedicated team that values Audacity, Care, and Energy. In this role, you will contribute to the CMC regulatory strategy and support the development, manufacturing, and lifecycle management of pharmaceutical products.

Your expertise will help to ensure compliance with regulatory requirements while facilitating the delivery of innovative therapies to patients. You will be part of a stimulating professional environment where personal and intellectual growth is encouraged.

Main Responsibilities:

• Support the preparation, review, and submission of regulatory documentation related to Chemistry, Manufacturing, and Controls (CMC) for drug development and marketed products.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to develop and implement CMC strategies.
• Assess regulatory impact of changes in manufacturing processes and provide recommendations for compliance.
• Assist in responding to regulatory inquiries and follow up with health agencies on CMC matters.
• Monitor industry trends and regulatory updates to ensure compliance with evolving guidelines.
• Support continuous improvement initiatives within the CMC function.

Requirements

Candidate Profile:

About the Job

At Excelya, we are committed to fostering an environment defined by Audacity, Care, and Energy. As a Clinical Operations Lead (USA), you will play a vital role in enhancing our clinical research strategies and ensuring operational excellence across our studies in the vibrant U.S. market.

This position offers a unique opportunity to lead a dedicated team while collaborating with various stakeholders to uphold the highest standards of quality in clinical operations. You will be instrumental in driving innovation and contributing to cutting-edge research initiatives that shape the future of healthcare.

Main Responsibilities

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Coordinate the local clinical team involved in national and international oncology trials.
• Participate in the development of study documents (protocols, ICFs, CRFs, etc.).
• Manage the study budget and timeline to ensure efficient execution.
• Oversee site and vendor selection, activation, and performance throughout the study.
• Ensure successful patient recruitment through coordinated clinical activities.
• Deliver study results with high quality, on time and within budget.
• Manage regulatory submissions and administrative follow-up in compliance with ICH-GCP and local regulations.
• Lead feasibility assessments and investigator selection.
• Provide transversal management and operational oversight of CRAs.

Requirements

About Excelya 
Excelya is a fastgrowing European CRO driven by the ambition to deliver the most engaging employee experience while becoming a leading player in clinical research. With more than 1,000 employees across 28 countries, we continue to expand and strengthen our organisation. 
As part of this growth, we are looking for a Senior Business Unit Manager to lead and develop one of our strategic Business Units, oversee a team of Business Managers, and drive operational and commercial excellence across a perimeter of approximately 70 consultants. 

Your Mission 

As a Senior Business Unit Manager, you will be responsible for the full operational, commercial and managerial performance of your Business Unit. Your responsibilities will include: 

Leadership & Team Management 

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

You will be responsible for the medical assessment of sensitive pharmacovigilance files, often consisting of numerous medical documents. Expertise in neurology, obstetrics‑gynecology, or pediatrics is particularly valuable.

Your role will be to produce clear, accurate, and clinically rigorous medical summaries, supporting medico‑legal evaluations within the context of compensation requests.

Main Responsibilities:

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Clinical Research Director, you will have the opportunity to lead and manage clinical development programs, driving innovation in clinical research while building and mentoring a high-performing team.

This role is integral to the success of our clinical trials as you will ensure compliance with regulatory requirements, study protocols, and Good Clinical Practices (GCP) while striving to deliver impactful treatments to patients globally.

Main Responsibilities:

Join Excelya, where Audacity, Care, and Energy define who we are and how we work.

We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand. This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

Main Responsibilities

• Contribute to RFP, SOW, and IRT risk assessment/mitigation plan.

• Organize kick-off and alignment meetings with stakeholders.

• Define IRT project requirements, data transfer specifications, and communication plan.

• Validate IRT study documents (protocol, plans, manuals) and microplanning. • Coordinate User Acceptance Testing (UAT) and review test plans for patient management.

• Oversee IRT vendor activities, meeting minutes, and issue logs.

• Ensure proper data transfer, reconciliation, and final quality control before IRT closure.

• File IRT study documentation in eTMF and contribute to lessons learned review.

Requirements

About You

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.