Live opening · Posted 3 days ago
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About the role
Description supplied by the original job listing.
Join Excelya, a company driven by Audacity, Care, and Energy, where innovation and collaboration are at the heart of everything we do.
As a Clinical Scientist, you will support the Study Medical Manager in the planning, execution, analysis, and reporting of clinical studies from study start-up through study close-out. You will contribute to protocol development, medical data review, study documentation, and cross-functional collaboration to ensure high-quality clinical trial delivery in compliance with regulatory requirements.
Key Responsibilities
Support and represent the Study Medical Manager throughout the clinical study lifecycle
Contribute to the development and review of key clinical documents, including protocols, protocol amendments, informed consent forms (ICFs), CRFs, and medical data validation plans
Perform medical review of patient data, listings, narratives, CIOMs, and clinical cases
Collaborate closely with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams to support data review and consistency checks
Review study-related documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs
Support the preparation and management of study committees, investigator meetings, and study training activities
Maintain medical and scientific documentation within the Trial Master File (TMF)
Draft responses to medical questions from Health Authorities, Ethics Committees, investigators, and study teams
Develop medical review guidelines and support outsourced medical review activities when applicable
Contribute to audit and inspection readiness activities and support responses to findings
Requirements
Advanced degree in Medicine (MD), Pharmacy (PharmD), Life Sciences, or related scientific discipline
Strong experience as a Clinical Scientist, Medical Scientist, Clinical Research Physician, or similar role
Experience supporting clinical studies in Immunology & Inflammation and/or Oncology
Strong understanding of clinical development, study design, and clinical trial conduct
Knowledge of ICH-GCP, regulatory requirements, and clinical research processes
Experience reviewing clinical data, patient profiles, narratives, and safety information
Familiarity with Clinical Study Reports (CSRs), protocols, and TMF documentation
Strong cross-functional collaboration and communication skills
Fluent English, written and spoken
Benefits
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.
Work arrangement
Yes
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