If you are a PhD with a clinical scientist experience, we invite you to apply for this role at one of our top clients, an innovative multi-million business unit of a world leading international corporation located in Neuchatel, Switzerland:
Senior Clinical Scientist
As a Senior Clinical Scientist you will act as the scientific leader for clinical studies and projects according to study planning, within the Clinical Science & Epidemiology (CSE) department, being also responsible to develop and review documents in line with ICH/GCP, provide scientific/clinical input and expertise to the team and support the clinical operations. We are conducting GCP clinical studies and now also focusing on consumers' needs and interests; you will design "out-of-the-box" studies/work on research to support consumer's claims.
More specifically, you'll:
- Lead the development of clinical study documents (protocol and amendments, summaries, fact sheets and reports including drafting and review process until approval. Provide input to study documents with scientific content: Inform Consent Form, Statistical Analysis Plan (SAP), Case Report Form, laboratory and analytical documentations. Review study data in line with Data Review Plan and clinical results: tables, figures, listings (TFLs) according to the SAP
- Ensure that the study documentation is developed following ICH-GCP, with respect to subject assessment of eligibility, enrollment, clinical safety (adverse events, serious adverse events), data consistency, as well as the quality management system (QMS) applicable to the R&D environment
- Participate to clinical operations activities requiring scientific input (internal and external meetings, investigator meetings, discussions with CRO/vendors/third parties). Contribute to the clinical assessment team activities (assessment plans, presentations, publications and literature searches), interact with other functions, external partners and 3rd parties. Collaborate with the clinical study, regulatory, quality and safety teams for the resolution of issues and crises
- Raise relevant information, ensure feedback is sought and a solution is achieved with no delay. Collaborate to write, review and update of SOPs/WKIs related to assessment activities. Work on the registration and publication of clinical studies/results on ClinicalTrials.gov and prepare the publication of results in peer-reviewed journals
- MD, PharmD or PhD (preferred) or equivalent skills through demonstrated experience
- Substantial experience in clinical research (academic, pharmaceuticals, medical devices, CRO), in planning, execution and reporting of studies. Thorough knowledge of clinical research, ICH/GCP, trial documents, design and regulatory processes
- Experience in consumer's research and claims in fields such as, for example, well-being or cosmetics, would be a great added value
- Good understanding of statistics. Proficient in performing literature review and familiar with document storage/systems, working according to a QMS
- Proficient in MS Word, PowerPoint and Excel
- Fluent in English, both written and spoken
This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest companies worldwide. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!