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Clinical Research Scientist Hematology/Oncology Boudry Switzerland,  

Posted on : 26 February 2017

Project Description

Req #: 17000261 Location: BOUDRY, NE CH Job Category: Medical Work Location: Boudry, Switzerland Route de Perreux 1 Boudry 2017 Organization: Celgene R&D Sarl Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Manager Travel: Yes, 10 % of the Time DescriptionPre-requisites: Advanced Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), minimum 2 years experience in clinical research development or equivalent Summary/Scope: The Clinical Research Scientist provides scientific and medical input into specific protocols for hematology/oncology compounds and disease areas through various stages of clinical development to support regulatory submissions worldwide.   This individual will work with a CRP and other CRS  to develop and implement hematology/oncology protocols in line with the clinical development plan. Responsibilities will include, but are not limited to, the following: 1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. 2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc. 3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). 4. Clinical study report preparation 5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc. 6. Participate in Development Planning for assigned compounds. 7. Oversee and challenges the adequacy of planning for study implementation 8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals 9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects 10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety) 11. Collaborates and supports operational activities as need be. 12. Assist in establishing project budgets 13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data. 14. Participate and present at investigator meetings 15. Participate in adhoc meetings  (e.g. marketing) 16. Assist in document template design and SOP writing 17. Participate on various corporate committees 18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required 19. Lead team meetings as required 20. Travel to investigator sites in the EU to assist in clinical management of ongoing studies; provides training as required   *LI-SL1Qualifications



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