The primary purpose of the Clinical Scientist's (CSc) position is to assist/support the Clinical Study Director (CSD) in the medical/scientific contribution for the clinical studies: e.g: contributing/reviewing of extended synopsis, protocols, amendments, amended protocols, support to medical review of study data (especially safety data with reconciliation), review of draft study reports or draft publications for accuracy, search of medical/scientific information for study teams, literature review and analysis, assists in the preparation of the responses for investigators, study teams, ethics committees or regulatory authorities, helps manage study committees.
Scope include all clinical trials for projects in development (excluding Phase I in healthy subjects, Phase I Onco and POC managed by CEP) and clinical studies (e.g. registries) for marketed drugs or devices, from scientific assessment of a clinical project to final deliverable (clinical study report, clinical part of a CTD).
Under the guidance of the CSD and/or medical operations management : he/she collaborates with the Coding specialist, Biostatisticians, CTOMs, R-TMs, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. review of narratives) on high quality medical review, as needed.
He/she supports the Leader, Transversal Functions and functionally to the CSD to ensure appropriate documentation and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
- Scientific expertise or interest and ability to learn in the domain of assigned study/project. - High level of autonomy and motivation
- Quality focused and well organized
- Strong communication skills (verbal and written)
- Ability to handle multiple tasks and to prioritize
- Ability to synthesize the information, good presentation skills
- Ability to work autonomously and to efficiently & effectively provide status reports
- Ability to anticipate and timely escalate issues and to define appropriate action plans
- Team and results oriented
- Strong English skills (verbal and written if English is the second language)
MD, Ph.D., Pharm.D., or similar; bachelor's degree considered for candidates with experience. Previous experience in Clinical Research and/or Drug Development (e.g., at least 5 years within pharma industry or CRO).
Knowledge in ICH, GCP.
Fluent in English.