Senior Global Trial Associate

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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

Responsibilities involve a combination of execution and oversight, dependent on the sourcing model, to ensure deliverables and may include, but are not limited to the following:

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.

• Resolves routine problems and escalates important issues appropriately (with a sense of urgency). 

• Actively contributes as a key functional member on cross-functional teams.

Study/Project Planning and Management​

• Provides and support input to study level tools and plans while working with moderate to minimal supervision.

• Independently performs core GTS tasks and escalates/pushes back/delegates appropriately.

• Actively contributes to study meetings by leading some components.

• Contributes to oversight of the required country regulatory (e.g., CTA, MoH) and country/site IRB/IEC approvals/notifications.

• Flexibility to work on various trials at varying stages/complexity with minimal guidance as needed.

• Understands strategy and decision making at program level and their impact on the studies.

• Ability to contribute to initiatives for process development and improvement.

• Ability to assess a situation and identify path forward with the appropriate resources.

• Understands interdependencies of tasks assigned.

• Manages vendors and site payment processing and tracking.

• Facilitate the maintenance of study budget tracking tools and reconciles invoices with overall contract/budget and finance reports.

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%.

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