BrightOwl Loader Loading

Clinical Research Scientist Hematology/Oncology Boudry Switzerland,  

Celgene (company)

Posted on : 26 February 2017

Project Description

  •  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: 
  • 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  

  • 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)



Find a Job Find Candidates

Similar Jobs

More jobs from Celgene

Other jobs in Switzerland

Other jobs in Boudry

Other jobs from Celgene in Boudry

Other similar job in Boudry

Other Jobs

Most Recent Searches

Most Famous Searches

You might also like