Clinical Scientist

Responsibilities will include:

• 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 haematology/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 (i.e. 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.

Skills/Knowledge Required:

• Minimum 6 yrs. experience in oncology/haematology 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), JReview, EDC (Rave)
• Demonstrated ability to work as part of a team.
• Haematology experience (plus). Protocol authoring (preferred).
• Data review and medical monitoring of data (required).