Job Details

  • Title: Specialist Study Management
  • Code: RCI-22904
  • Location: Wilmington, DE 19850
  • Posted Date: 06/23/2022
  • Duration: 5 Months
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  Job Description

Ideal Candidate Profile:

  • Bachelor’s degree is preferred
  • 3-5 years of experience in clinical trials and regulatory documents is required
  • Veeva experience a plus
  • Accountable and inquisitive; thinks "outside the box"
  • 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 - Candidates must be local to Wilmington, DE; non-remote position

Responsibilities:

  • 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).

 Skills and Competencies

  • 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, excellent attention to detail, and ability to multi-task in a high volume environment with shifting priorities
  • Team oriented and flexible; ability to respond quickly to shifting demands and opportunities
  • Integrity and high ethical standards