- Expiry Date: 02 October 2021
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.
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
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
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