Clinical Trial Application Coordinator
Waltham, MA | Contract
Title: Clinical Trial Application Coordinator
Duration: 8 Months
Location: Waltham, Massachusetts
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
• 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.