Clinical Trial Application Coordinator

Waltham, MA | Contract

Post Date: 04/12/2018 Job ID: 226102 Industry: Life Sciences

 

Title:                     Clinical Trial Application Coordinator
Type:                    Contract
Duration:            8 Months
Location:             Waltham, Massachusetts

Description:

This regulatory affairs job is responsible for coordinating the regulatory clinical trial applications (CTA) submission activities for assigned clinical trials.
This role is 100% onsite

Job Responsibilities:

•             The Regulatory Clinical Trial Application Coordinator will represent Regulatory Affairs in the study management teams. This will include providing regulatory strategy and overseeing activities conducted by the contract Research Organization
•             Will facilitate the gathering of or author documents to be included in the clinical trial application
•             The Regulatory Clinical Trial Application Coordinator role will be the primary contact point between Regulatory and the CRO for the management of submissions of CTAs.
•             The Regulatory Clinical Trial Application Coordinator will ensure that the submission and approval events are tracked and the Master File is maintained.  

Education, Skills and Experience:

•             Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is preferred
•             Proven experience in preparing and making clinical trial applications outside of the U.S.
•             Familiar with the Clinical Trial Directive in the European Union
•             Knowledgeable with scientific terminology.
•             Ideal candidate would possess proven experience within regulatory affairs in the pharmaceutical industry.
•             An understanding of drug development, clinical trial authorization applications, Regulatory Affairs, and associated regional and national requirements for conducting Rest of World clinical Trials
•             Must have strong communication skills (written and verbal)
•             Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency).
•             Ability to lead complex projects and a high degree of problem solving capability required.
•             Must be able to work independently, strong initiative.

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