Clinical Trials Specialist

1 day ago


Wilmington, Delaware, United States Fladger Assoc. Inc. Full time
Job Title: Clinical Trials Specialist

Fladger Assoc. Inc. is seeking a highly skilled Clinical Trials Specialist to join our team. As a key member of our clinical operations team, you will be responsible for managing clinical trials from start to finish, ensuring compliance with regulatory requirements and company policies.

Key Responsibilities:
  • Manage and maintain quality for the study file as the local study team TMF owner
  • Own and maintain site communications and other portal management
  • Run and analyze reports from multiple systems
  • Responsible for Vendor Management
  • Handle requests for CTMS updates
  • Operational responsibility to set-up the local Trial Master File (eTMF) including tracking of documents
  • Maintain and close the local TMF ensuring International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) compliance and local requirements
  • Support the CRA in the maintenance and close out activities for the ISF
  • Contribute to the production and maintenance of study documents, ensuring template and version compliance
  • Contribute to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e., Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities

Requirements:

  • Bachelor's Degree is preferred
  • 3-5 years of experience in Clinical Trials and Regulatory documents is required
  • Veeva experience a plus
  • Must be methodical, compliant to processes yet flexible when needed
  • High ability to manage priorities and Local Study Team expectations
  • Independent yet able to work cohesively with a team
  • Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents
  • Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH/GCP guidelines
  • Working knowledge of clinical study documents
  • Ability to develop advanced computer skills to increase efficiency in day-to-day tasks
  • Good verbal and written communication
  • Good interpersonal skills and ability to work in an international team environment
  • Willingness and ability to train others on study administration procedures
  • Display excellent organization and time management skills


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