Specialist Study Management

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