Clinical Study Management Specialist

11 hours ago

Wilmington, Delaware, United States Fladger Assoc. Inc. Full time
Position Overview

Fladger Assoc. Inc. is seeking a dedicated Clinical Study Management Specialist to oversee various aspects of clinical trials. This role is essential for ensuring compliance and quality in study management.

Key Responsibilities:

  • Act as the primary custodian of the study file, ensuring all documentation is accurate and up-to-date.
  • Facilitate effective communication with study sites and manage portal activities.
  • Generate and interpret reports from diverse systems to support study progress.
  • Oversee vendor relationships and ensure their compliance with study requirements.
  • Manage requests for updates within the Clinical Trial Management System (CTMS).
  • Establish and maintain the local Trial Master File (eTMF), ensuring all documents are tracked appropriately.
  • Ensure adherence to International Conference of Harmonisation Guidelines for Good Clinical Practice (ICH/GCP) and local regulations.
  • Assist Clinical Research Associates (CRAs) with maintenance and closure tasks for the Investigator Site File (ISF).
  • Contribute to the creation and upkeep of study documents, ensuring compliance with templates and version control.
  • Support electronic submissions by managing clinical-regulatory documents in line with Submission Ready Standards (SRS).

Qualifications:

  • A Bachelor's Degree is preferred.
  • 3-5 years of relevant experience in Clinical Trials and Regulatory documentation is required.
  • Familiarity with Veeva is advantageous.
  • Must demonstrate a methodical approach while remaining adaptable to changing circumstances.
  • Strong ability to prioritize tasks and manage expectations within the Local Study Team.
  • Capable of working independently as well as collaboratively within a team environment.
  • Experience with electronic trial master file systems, including document upload, review, quality control, and approval processes.
  • Comprehensive understanding of the Clinical Study Process and associated procedures, including ICH/GCP guidelines.
  • Proficient in clinical study documentation.
  • Ability to enhance computer skills for improved efficiency in daily operations.
  • Excellent verbal and written communication skills.
  • Strong interpersonal skills, with the ability to thrive in an international team setting.
  • Willingness to mentor others on study administration practices.
  • Exceptional organizational and time management abilities.

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