Requirements: English
Company: Excelya
Region: Magny-les-Hameaux , le-de-France
Why Join Us?
At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare.
Heres what makes us unique
We are a young, ambitious health company representing 900 Excelyates, driven to become Europes leading mid-size CRO with the best employee experience. Our one-stop provider service modeloffering full-service, functional service provider, and consultingenables you to evolve through diverse projects. Working alongside preeminent experts, you will help improve scientific, operational, and human knowledge to enhance the patients 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.
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
Missions :
- Support and represent the Study Medical Manager in all oncology study-related activities from set up to closure.
- Contribution to the elaboration of the document relating to the trials: abbreviated protocol, protocol, informed consent (ICF), protocol and ICF amendments, medical data validation plans, answers to medical questions, contribution to various meetings (investigators, monitors, etc.), management of study committees preparation.
- Medical review of data on patient profiles, listings and CIOMs.
- Close collaboration with Trial Operations (TO), pharmacovigilance (CME / GSO) and statistics for the establishment of the listings necessary for the review of data consistency.
- Review of study-related documents: CRF, CRF completion instructions, deviations list, validation plan, protocol review form, ...
- Contribution to the review of interim and final studies reports, associated statistical tables and draft publications.
- Medical review of files, reviews of medical listings and contribution to the management of clinical studies (writing of protocols, basic clinical analysis, study set-up, medical training, medical responses) in the field of oncology studies, regardless of the type of study.
- Medical review and Guidelines to be written for medical reviews in the context of outsourcing or whenever applicable
About You
At Excelya, taking audacious steps is encouraged, so were looking for individuals who are ready to grow with us and share our values.
- Experience: Proven ability to thrive in collaborative, fast-moving environments (avoid requiring minimum yearstalent matters most to us!)
- Skills: Strong organizational abilities, problem-solving mindset, and excellent communication skills
- Education: Knowledge in immunology is recommanded
- Languages: Fluency in French & good level in English