New Jersey All, NJ
- 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
- Degree in life sciences
- Clinical/Medical background and experience working as a Clinical Research Scientist
- Candidate must have experience working on clinical trials as a Clinical Research Scientist from a sponsor's perspective
- Must have at least two years of direct hematology/oncology experience
- 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, J-review or other clinical databases or other data review tools (patient profiles, listings)
- Some experience in medical writing such as authoring or co-authoring documents such as protocol, clinical study report, investigators brochure, patient narrative, etc.
- Ability to communicate medical or clinical information to a physician