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.
Summary:
The clinical scientist is responsible for providing scientific expertise throughout the development and implementation of clinical studies. Responsible for the design, execution, and monitoring of internal and external clinical studies. Follows standard and complex procedures in executing studies, evaluation and documentation of results. Writes/manages clinical plans or reports, or clinical trial protocols, protocol amendments, risk master lists, clinical trial registrations and results postings, clinical study project timelines and scientific publications.
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: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
