- Expiry Date: 07 November 2021
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 oncology/hematology data including but not limited to: safety, primary efficacy variables, and laboratory data.
Assist with clinical document preparation (writing, reviewing, amending and cross-functional facilitation as appropriate).
Assist with clinical study report preparation to include narrative writing
Participate in adhoc meetings
Support clinical trial activities as requested
Minimum 5 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 review and interpretation
Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions
Full understanding GCP and ICH Guidelines
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
Oncology/Hematology experience (required); Registry experience (plus). Protocol authoring (plus). Data review and medical monitoring of data (required).
Qualifications: Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years experience in clinical research development or equivalent
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