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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.
- ID: #23268514
- State: New Jersey Summit 07901 Summit USA
- City: Summit
- Salary: BASED ON EXPERIENCE
- Job type: Contract
- Showed: 2021-11-22
- Deadline: 2022-01-20
- Category: Science/biotech