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Scientific. Clinical. Software Engineering

Senior Clinical Scientist

New Jersey All, NJ

Job Type: Clinical Job Number: JN -062020-26956 Region: New Jersey All

Job Description

Review of clinical data within eCRF system, patient profiles, etc. to issue queries and clean data from clinical perspective

Conduct review of ongoing summary data including: safety, primary efficacy variables, and laboratory data

Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management

Prepare key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc.

Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate)

Clinical study report preparation

Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc.

Participate and/or Lead team meetings as required

Skills/Knowledge Required

Bachelor s Degree

Candidate must have recent experience working as a Clinical Research Scientist from a sponsor (pharmaceutical or biotech) company

Must have at least two years of direct Hematology/Oncology Clinical Science experience (CAR T Cell Therapy is a plus)

Must have experience performing data review in Hematology/Oncology indications

Experience in performing review of clinical trial data in order to identify trends in safety or efficacy data

Ability to function independently in data review to identify discrepancies in clinical trial data and to write queries from a medical perspective

Familiarity with Medidata, RAVE, JReview or other clinical databases and data review tools (patient profiles, listings)

Experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative

Ability to communicate medical or clinical information to a physician

Ability to understand clinical trial publications; understanding of disease

Must be able to function independently

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