Senior Global Trial Associate

Position Summary

The Senior Global Trial Associate contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities' regulations/guidelines, and applicable SOPs/WPs. The Sr. GTA participates on one or more cross-functional study team(s) and/or performance and quality oversight of one or more Contract Research Organization (CRO) teams and vendors. He/She primarily works on routine to complex projects/trials at varying stages and supports multiple complex trials as needed with moderate to minimal supervision.

Duties & Responsibilities

• Project Management
• Manages the development and/or collection of study level documentation & support
• Global Trial Lead (GTL) in ensuring eTMF accuracy & completion of for all studies
• Provides operational input and facilitates operational processes as an SME in support of the startup, maintenance, and closure of studies
• Uses performance metrics and quality indicators to assist the Global Trial Lead (GTL) in driving study execution
• Proactively Identifies risks and develops/implements action to avoid or mitigate
• Solves routine problems and escalates important issues appropriately (with a sense of urgency)
• Actively contributes as a key functional member on cross-functional teams

Education & Experience

• BA/BS in relevant discipline strongly preferred
• Minimum 2-4 years’ experience in Clinical Research or related work experience
• Global experience is preferred
• Experience in the use of industry Clinical Trial Management Systems and Clinical Trial Master File Systems
• Knowledge of ICH/GCP, regulatory guidelines and directives, and the drug development process
• Knowledge of clinical research budgets including processing and tracking of site and vendor payments is preferred
• Working knowledge of project management preferred
• Travel required less than 5%