Our client, a leading pharmaceutical company, is hiring a Clinical Scientist on a contract basis.
1. 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.
2. Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data.
3. Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
4. Assist with Study Start up Activities and data base build
5. Participate or lead in Scientific meetings (ie Ad-Board, Steering Committee, Data Monitoring Committee)
6. Potentially assume study lead responsibilities, manage study, work independently
7. Multi-tasking, i.e working on multiple studies and/or multiple deliverables
– 6 yrs. experience in oncology/hematology clinical development
– Excellent written and verbal communication skills and interpersonal skills.
– 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), J-Review, EDC (Rave)
– Demonstrated ability to work as part of a team
Hematology experience (plus). Protocol authoring (preferred). Data review and medical monitoring of data (required).
Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), 5 years experience in clinical research development or equivalent