Senior Clinical Scientist - Oncology (Lymphoma)
Skills: Clinical Development,Clinical Scientist,Oncology
- 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
- Minimum 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
Experienced at cleaning both safety and efficacy data (not just safety)
Capable of leading a complex combination therapy trial with little supervision
- Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
- Full understanding GCP and ICH Guidelines
- Phase 1 expereince is a plus
- 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 pharmacy or related medical field), minimum 5 years’ experience in clinical research development or equivalent