Join Excelya as a Clinical Scientist Rare Disease and contribute to a dynamic team in Clinical Operations.

Requirements

Support and represent the Study Medical Manager in all study-related activities from setup to closure.
Contribute to the development of trial-related documents, including protocols, informed consent forms (ICF), and amendments.
Draft responses to medical queries from regulatory authorities, ethics committees, clinical sites, and study teams.
Assist in the preparation and management of study committees, including member selection, charter development, and documentation.
Maintain and organize medical and scientific documents in the Trial Master File (TMF).
Conduct clinical case reviews, patient profile assessments, and validation of narratives.
Collaborate closely with Trial Operations, pharmacovigilance, and statistics teams for data review and reporting.
Review key study documents, such as risk management plans, CRFs, monitoring plans, and deviation lists.
Contribute to the review of interim and final study reports, statistical tables, and clinical study reports (CSRs).
Prepare for audits and inspections by ensuring compliance with medical review guidelines and regulatory standards.

Benefits

Join Excelya as a Clinical Scientist Rare Disease and contribute to a dynamic team in Clinical Operations.

Support and represent the Study Medical Manager in all study-related activities from setup to closure.
Contribute to the development of trial-related documents, including protocols, informed consent forms (ICF), and amendments.
Draft responses to medical queries from regulatory authorities, ethics committees, clinical sites, and study teams.
Assist in the preparation and management of study committees, including member selection, charter development, and documentation.
Maintain and organize medical and scientific documents in the Trial Master File (TMF).
Conduct clinical case reviews, patient profile assessments, and validation of narratives.
Collaborate closely with Trial Operations, pharmacovigilance, and statistics teams for data review and reporting.
Review key study documents, such as risk management plans, CRFs, monitoring plans, and deviation lists.
Contribute to the review of interim and final study reports, statistical tables, and clinical study reports (CSRs).
Prepare for audits and inspections by ensuring compliance with medical review guidelines and regulatory standards.