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

This position offers a unique opportunity to lead strategic CMC regulatory initiatives while collaborating with cross-functional stakeholders to ensure the highest standards of quality and compliance. You will play a key role in driving regulatory excellence, supporting complex global submissions, and contributing to innovative development and lifecycle management strategies that shape the future of medicines.

Main responsibilities :

Define and lead the CMC regulatory strategy for complex projects, providing proactive guidance and expertise to cross-functional technical teams

Develop and maintain a global regulatory roadmap, ensuring alignment between manufacturing changes, regulatory requirements, and supply chain constraints

Oversee the preparation and submission of CMC dossiers, ensuring the robustness of comparability, validation, and quality data

Coordinate global regulatory submissions, optimizing timelines and ensuring compliance with regional requirements

Lead and manage interactions with Health Authorities, including addressing technical questions and supporting negotiations to facilitate approvals

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 Pharmacovigilance. 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:

• Supervise pharmacovigilance case management outsourced to assigned platform(s)
• Respond to case-related emails and inquiries from external service providers
• Monitor case processing timelines and investigate any delays in reporting or transmission
• Participate in weekly quality control of data entry, MedDRA coding, and narrative writing
• Support the review and validation of clinical study case narratives for inclusion in study reports
• Contribute to the reconciliation of PV cases with business partners per Safety Data Exchange Agreements (SDEAs)
• Oversee reconciliation of cases with clinical databases managed by outsourced providers
• Collaborate closely with cross-functional and global teams to ensure compliance and data integrity

Requirements

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Clinical Research Director for Inflammation and Immunology (I&I), you will lead critical clinical programs and play a pivotal role in advancing innovative therapies for patients.

This remote role empowers you to influence clinical strategy significantly, ensuring that we not only meet regulatory standards but also create optimal study designs that translate into successful patient outcomes.

Main Responsibilities:

Lead the clinical development of projects in the Inflammation and Immunology therapeutic area from inception through to the successful execution of clinical trials

Ensure compliance with regulatory requirements, ICH-GCP principles, and internal procedures throughout the trial lifecycle

Develop and approve key clinical documents including protocols, informed consent forms, and study amendments

Work closely with cross-functional teams to define clinical strategy, operational processes, and delivery timelines

Serve as the primary medical and scientific contact for Health Authorities, Ethics Committees, investigators, and key stakeholders

Oversee and guide the design, governance, and conduct of clinical committees, ensuring adherence to governance standards

About the Job

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

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 Data Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

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 Data Management. 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.

The Oracle Programmer is responsible for providing Oracle Programming input for Data Management activities dedicated to one Sponsor. They are responsible for ensuring all clinical programming aspects per Client’s SOPs are delivered to high quality.  

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 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. 

The Study Medical Reviewer is accountable for managing/reviewing the medical consistency of reported clinical data to ensure that medical data in database are accurate, reliable and analyzable. He/Her has the responsibility of his/her studies/projects to provide reliable and consistent data from a medical point of view and to bring medical expertise to all processes from the set-up to the lock of the study.

Main Responsibilities

Position Overview: As a CRA Manager at Excelya, you will lead and oversee a team of Clinical Research Associates to ensure the successful monitoring and management of clinical trials. You will be responsible for maintaining high-quality standards, ensuring compliance with regulatory guidelines, and driving continuous improvement within the team. This role requires strong leadership, excellent communication skills, and a deep understanding of clinical research processes.

Key Responsibilities:

• Manage and supervise a team of CRAs, providing guidance, training, and performance evaluations.
• Ensure clinical trial monitoring activities adhere to ICH-GCP guidelines, standard operating procedures (SOPs), and regulatory requirements.
• Coordinate with project teams to ensure timely study execution and resolve site issues.
• Monitor study progress and data quality through regular communication with sites and internal stakeholders.
• Implement best practices for clinical monitoring and promote a culture of excellence within the team.
• Support recruitment, onboarding, and professional development of CRA team members.
• Participate in strategic planning to optimize clinical operations and resource management.

Requirements

Qualifications and Skills:

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 Regulatory. 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:

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 Regulatory. 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: