
501 - 1000 employees
Founded 2014
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.
🔥 4 minutes ago
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501 - 1000 employees
Founded 2014
💼 Consulting
🏥 Healthcare
📦 Logistics
Consulting • Healthcare • Logistics
Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.
• Support and represent the Study Medical Manager throughout the clinical study lifecycle • Contribute to the development and review of 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 with Clinical Operations, Pharmacovigilance, Biostatistics, and Data Management teams on data review and consistency checks • Review study documentation and contribute to interim analyses, Clinical Study Reports (CSRs), publications, and statistical outputs • Support 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
• 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
• Opportunity to grow through diverse and stimulating projects • Collaboration with leading experts • Contribution to scientific, operational, and human knowledge • Environment valuing natural talents and encouraging boldness • Opportunities to push boundaries and cultivate professional potential • Employee experience at a young and ambitious healthcare company • Work with a one-stop provider service model combining full-service, functional service provider, and consulting • Teamwork-focused environment • Contribution to improving the patient journey
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