Specialist Study Management

2 weeks ago


Wilmington, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionWilmington, DEContract Duration: 12-36 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area. Candidates must be local to Wilmington, DE, non-remote position
  • Own and maintain quality for the study file as the local study team TMF owner
  • Responsible for site communications and other portal management
  • Running and analyzing 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 (not for international studies).

Experience:

  • 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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