Clinical Scientist With Clinical Study Data Review

CLINICAL SCIENTIST WITH CLINICAL STUDY DATA REVIEW SUMMIT, NJ Position may start remote then move to a hybrid schedule of 2-3 days a week Onsite. Project Description:

• 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 (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 .

• We need candidates with management of clinical study, data review experience, protocol development / writing experience.
• 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 .
• Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions .
• Full understanding Google Cloud Platform 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 .
• Data review and medical monitoring of data required.
• Advanced Degree in Life Sciences (e.g., nursing, pharmacy, or related medical field), minimum 5 years' experience in clinical research development or equivalent .

• Hematology experience a plus.
• Protocol authoring preferred.