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Clinical Scientist

New Jersey All, NJ

Posted: 08/09/2019 Job Type: Clinical Job Number: JN -082019-25404

Provide scientific clinical leadership in conducting extensive data review in RAVE under minimal guidance and oversight from his/her supervisor

Review and query of hematology data including but not limited to: eligibility criteria, primary efficacy variables, pathology, anti-MM therapies, and laboratory data

Coordinate with contract research organization (CRO) and liaise with clinical sites for timely data completion

Support with clinical study report preparation

Participate in ad-hoc meetings

Support clinical trial activities as requested

Specific Requirements:

BA/BS degree; advanced degree preferred

3-5 yrs. experience in oncology/hematology clinical science experience

Proficient at data review and interpretation

Knowledge of clinical trial design, basic statistics, and data review tools

Must have knowledge and expertise in MedDRA, Who drug dictionary, TMF, eSub JReview, Excel and RAVE

Experience in protocol development and regulatory submissions

Ability to assimilate technical and scientific information quickly

Proficient in Excel, EDC (RAVE). Proficient in Microsoft Office (Word, PowerPoint; Microsoft project) and SAS a plus

Excellent written and verbal communication skills and interpersonal skills

Be willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required

Detail-oriented, well-organized

Demonstrated ability to work as part of a team

Protocol authoring

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