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Clinical Research Scientist Hematology/Oncology Boudry Switzerland,  

Celgene (company)


Posted on : 26 February 2017

Project Description


Description
Pre-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
Responsibilities will include, but are not limited to, the following: 
  • Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management.
  •  Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.
  • Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). 
  •  Clinical study report preparation  5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.
  • Participate in Development Planning for assigned compounds. 
  • Oversee and challenges the adequacy of planning for study implementation
  • In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals 
  • Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects 
  • Work with department managers to prioritize project/study timelines to ensure adequate staffing .
  • Collaborates and supports operational activities as need be.
  • Assist in establishing project budgets 
  • Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data.
  • Participate and present at investigator meetings 
  • Participate in adhoc meetings  (e.g. marketing) 
  • Assist in document template design and SOP writing
  • Participate on various corporate committees  
  • Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required
  • Lead team meetings as required
  • Travel to investigator sites in the EU to assist in clinical management of ongoing studies; provides training as required  


Qualifications
  • Minimum 2 yrs. experience in medical or technical writing 
  • Hematology/Oncology Experience  
  • Clinical monitoring experience preferred 
  • Knowledge/exposure to allogeneic stem cell transplant or other cellular therapies preferred.
  • Excellent written and verbal communication skills and interpersonal skills.   
  • Extensive medical/scientific and clinical research knowledge
  •  Knowledge of Medical Terminology
  •  Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics 
  • Proficient at data interpretation 
  • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions 
  • Experience in all aspects of the drug development process 
  • Knowledge of GCP and ICH Guidelines 
  • Detail-oriented, well-organized
  • EU Travel required 
  • Ability to assimilate technical and scientific information quickly
  •  Clinical project management skills
  •  Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project and JReview a plus
  •  Demonstrated ability to work as part of a team 
  • High level of interpersonal and communication skills (written and verbal)

Locations

BOUDRY NE CH

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