Clinical Scientist

1 week ago

new york city, United States The Judge Group Full time

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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