Clinical Scientist

TSR Consulting Services provides best in class staffing solutions to clients nationwide, by staying true to our relentless focus of exceeding the highest professional IT service business standards. Today, as a NASDAQ company specializing in IT consulting and staff augmentation, TSR continues to expand and transform its services to meet and anticipate its client’s and candidate’s’ needs. For more than 53 years, TSR's has been a leader in the industry because of our expertise and knowledge of the job market, our compassion and caring of our clients and consultants and our work environment of respect and inclusion. Your career is in good hands with TSR because at the end of the day, if YOU THRIVE, WE THRIVE.


Our client, a leading Pharmaceutical company is hiring a Clinical Scientist on a contracting basis.

Work Location: Summit NJ

Summary:

• Assist the Clinical Research Scientist team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management
• Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data
• Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)
• Assist with Study Start up Activities and data base build
• Participate or lead in Scientific meetings (ie Ad-Board, Steering Committee, Data Monitoring Committee)
• Potentially assume study lead responsibilities, manage study, work independently
• Multi-tasking, i.e working on multiple studies and/or multiple deliverables
   

Required Skills:

• Minimum 6 yrs. experience in oncology/hematology clinical development
• Knowledge of clinical trial design, basic statistics, and data review tools
• Proficient at data interpretation
• Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
• Full understanding GCP and ICH Guidelines
• Detail-oriented, well-organized
• Ability to assimilate technical and scientific information quickly
• Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave)
• Protocol authoring (preferred)
• Data review and medical monitoring of data (required)