Clinical Trial Manager (CTM / Clinical Operations) - Newton, MA
A pharmaceutical company in Newton, MA is seeking a clinical trial manager (CTM) to join their clinical operations team. The clinical trial manager will play a key role in managing clinical trials and acting as a liaison between the client and external vendors. The clinical trial manager must be able to be onsite in Newton, MA 3 days a week.
* Manage assigned study activities within agreed upon timelines and budget and in accordance with SOPs, GCP and all applicable laws and regulations
* Reviews monitoring reports to ensure quality and resolution of site-related issues
* Manages clinical trial vendor and site relationships
* Contribute to CRO/vendor selection
* Budgets, timelines, and forecasts preparation for clinical studies
* Oversee management of CRF data (EDC), trial-related documents in the Trial Master File (TMF)
* Participate in Case Report Form design, user acceptance testing in partnership with data management
* Mentor junior staff on the clinical operations team as needed
* 4+ years of clinical research experience - Previous Pharma/Biotech/CRO experience is a MUST
* Experience managing complex studies (i.e. Oncology, Gene Therapy, Rare Disease, etc.) is preferred
* Strong written and oral communication skills
* Self-starter and able to work with a team
If you are interested in exploring this position, please email your CV to j.segal(at sign)realstaffing.com
Sthree US is acting as an Employment Business in relation to this vacancy.