About the role
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.
Originally posted on Himalayas