Specialist Study Management

Wilmington, DE


Contract Duration: 12-36 months


Rate: Negotiable


Salary: NA $1.00

• Excellent employment opportunity for a Specialist Study Management in the Wilmington, DE area.
• Operational responsibility to set-up the local Trial Master File (eTMF) and Investigator Site File including tracking of documents.
• Maintain and close the local TMF (in electronic or paper form depending on study) 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.
• Create and/or import clinical-regulatory documents into the Global Electronic Library (GEL) according to the Global Document List (GDL) ensuring compliance with the company Authoring Guide for Regulatory Documents to support publishing in GEL
• 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).
• Set-up, populate and accurately maintain information in company tracking and communication tools (e.g. IMPACT, SharePoint etc.) and support others in the usage of these systems

• Bachelor's degree is preferred
• 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT 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
• Independent yet able to work cohesively with a team
• Candidates must be local to Wilmington, DE; non-remote position
• 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
• Willingness and ability to train others on study administration procedures
• Display excellent organization and time management skills