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Specialist Study Management
1 month ago
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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