Clinical Scientist
3401 Princeton Pike Trenton, NJ 08648 US
Job Description
Target Pay Rate: 70-80.03/hr **salary will be commensurate with experience
Job Description:
Research and Early Development
The Early Development Clinical Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs.
- Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct.
- May lead or support trial level activities for one or more trials with the necessary supervision.
- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices with instruction.
- Provide regular and timely updates to manager/management as requested.
- Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required.
- Conduct literature review.
- Develop site and CRA training materials and present these at SIVs and Investigator meetings.
- Review clinical narratives.
- Collaborate cross-functionally to monitor clinical data for specific trends.
- Contribute to the development of Data Review Plan in collaboration with Data Management.
- Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)
- Submit clinical documents to TMF
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field preferred).
- Expectation of 2+ years of experience in clinical science, clinical research, or equivalent.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol(s) and their requirements.
- Knowledge and skills to support program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
- Basic planning/project management skills (develop short range plans that are realistic and effective)
- Basic knowledge of disease area, compound, current clinical landscape.
- Detail-oriented with commitment to quality
- Intermediate critical thinking and problem-solving skills.
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., patient profiles, report generating tools)
- Domestic and international travel may be required (approximately 10-20%)
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