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Clinical Scientist

Clinical Scientist

The Judge GroupRemote, US
30+ days ago
Salary
$170,000.00 yearly
Job type
  • Permanent
  • Remote
Job 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 (. 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 (. 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.