- Partners with other clinical scientists and medical monitor on oversight of clinical trial activities, including safety reviews and site interactions
- Organize and lead process for review of potential patients for study participation
- Review, analyze, and interpret emerging clinical trial data
- Liase with the broader clinical development team at Verve (clinical operations, data management, and regulatory teams)
- Contribute to authoring key study and regulatory documents (e.g. protocol, ICF, study manuals)
- Leads internal meetings to review topics and develop mitigation plans
- Contribute to the development of presentations emerging from clinical studies
- Ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and Verve SOPs
- Other duties as assigned
- Healthcare degree required such as RN, NP, PA, BSN, MSN, Pharm D
- 7+ years of clinical healthcare experience with a BS level degree
- 5+ years of clinical healthcare experience with an advanced degree
- Experience ideally in internal medicine or cardiology.
- Experience with clinical research studies or clinical development experience in industry is preferred.
- Familiarity with key clinical study documents
- Experience with the review of clinical data
- Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies
- Experience working with CROs and external vendors not required but a plus
- Strong attention to detail and organizational skills
- Exceptional verbal and written communication skills
- Ability to build strong relationships and work effectively with cross-functional teams
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Senior Clinical Scientist - Boston, United States - Verve Therapeutics Inc
Description
The Position
Verve is seeking an experienced Senior Clinical Scientist to join our team as we continue to advance gene editing medicines for cardiovascular disease into clinical development.
In this position, you will be an integral part of the clinical development team supporting the execution of early phase clinical studies.
You will report to the Senior Director, Clinical Research.The ideal candidate will have outstanding communication skills, attention to detail, and the ability to thrive independently in a highly innovative and fast paced environment.
Job Responsibilities
