Job Description:
Location: REMOTE
Salary: $140,000.00 USD Annually - $170,000.00 USD Annually
Description: Our client is currently seeking a Clinical Scientist for a permanent/direct hire position that can sit remotely, but will require occasional onsite visits to the NYC area.
Description
- Review, analyze, and interpret emerging clinical trial data (including biomarkers, clinical pharmacology, and safety data) and lead preparation for key study meetings (e.g. investigator meetings, monitoring committees, advisory boards)
- Collaborate with the medical monitor on oversight of clinical trial activities, including safety reviews and site interactions.
- Communicate with the broader clinical development team (clinical operations, data management, and regulatory teams)
- Contribute to the writing of key study and regulatory documents (e.g. protocol, ICF, study manuals, briefing books)
- Lead internal meetings to review topics and develop mitigation plans.
- Contribute to the creation of presentations, abstracts, and publications emerging from clinical and translational studies.
- Work with clinical and research teams to implement the clinical biomarker strategy for early phase clinical studies.
- Ensure all activities comply with ICH/GCP guidelines, applicable regulatory requirements, and SOPs
- Perform other duties as assigned.
Required Education/Qualifications/Skills:
- A degree in Life Sciences (MD, PhD, Pharm D, MS or similar scientific field preferred).
- At least 5+ years of experience in clinical science, clinical research, or equivalent is expected.
- Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Basic understanding of disease area, compound, current clinical landscape.
- Ability to write regulatory documents and lead clinical scientist tasks.
- Knowledge and skills to support program-specific data review and trend identification.
- Advanced medical writing skills and medical terminology.
- Basic knowledge of the establishment and operation of data monitoring committees, medical review teams, and adjudication committees.
Contact: jgearhart@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
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