Senior Clinical Trial Associate-Greater Boston Area
Senior Clinical Trial Associate
A Boston-Area pharmaceuticals company is seeking a Senior Clinical Trial Associate to join their team. The Senior Clinical Trial Associate will be help the Clinical Operations team deliver Clinical Development objectives and attain Clinical Excellence by overseeing TMF, study insurance request management, study budget, legal/administrative document tracking, CTMS updates, and transparency declarations. The Senior Clinical Trial Associate will need to have excellent organizational and communication skills.
- Support clinical development team in the overall management of studies
- Assist in the planning, execution, and closeout of outsourced clinical trials
- Assist the CPM in site management activities such as the review of monitoring reports, tracking of site visits, and maintain contact with necessary monitors and sites
- Collaborate with and assist clinical project managers to prepare all external and internal documentation for assigned trials to assure it's completed in accordance with GCP regulatory requirements and consistent with the study protocol.
- Assist in the creation of and distribution of study materials and communicate the materials to KOLs, CROs and other external vendors.
- Organize and prepare study files related to study tracking and reporting and submit them to the Trial Master File
- Aid the project team with planning, preparation and possible on-site support of investigator's meetings
- Support invoice and budget activities
- Bachelor's degree with a life science or healthcare focus
- A minimum of 2+ years of supporting clinical studies at a hospital, CRO or biopharma company
- Strong interpersonal, organizational and multi-tasking skills; attention to detail
- Working knowledge of ICH GCP regulations and clinical protocols
- Sound analytical and problem- solving skills; ability to act with a consistent sense of urgency
Sthree US is acting as an Employment Business in relation to this vacancy.