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Clinical Scientist (Hematology/Oncology)

  • Location: Summit, Union, New Jersey
  • Job Type:Contract

Posted 18 days ago

  • Expiry Date: 02 October 2021

​​Job Description:

MUST HAVE:

  • Experience as a Clinical Research Scientist (not laboratory or bench science!) in the pharmaceutical industry

  • Clinical/Medical background and solid experience performing data review within EDC systems and using tools like jReview, Spotfire, etc.

  • Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development capacity, experience in CAR T Cell Therapy , Lymphoma or Multiple Myeloma a PLUS.

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 or assist with preparation of 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

  • Candidate must have experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective in the pharmaceutical industry.

  • Must have at least two years of direct HEMATOLOGY/ONCOLOGY experience in a Clinical Research and Development, Clinical Science capacity

  • Must have experience performing data review in HEMATOLOGY/ONCOLOGY indications, CAR T Cell Therapy and/or Multiple Myeloma experience a plus (note, this position is different in scope from a CRA position or clinical operations)

  • 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, J-review, Spotfire or other clinical databases or other data review tools (patient profiles, listings) would demonstrate the candidate's familiarity with the scope of work.

  • Some 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

  • Degree in life sciences

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

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