Clinical Study Specialist With Documentation Managment

CLINICAL STUDY SPECIALIST WITH DOCUMENTATION MANAGMENT WILMINGTON, DE Hybrid. MUST be able to work in the Wilmington office a minimum of 3 days per week. Project Description:

• 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/Google Cloud Platform) 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).

• Bachelor's degree is preferred.
• 3-5 years of experience in clinical trials and regulatory documents is required.
• 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/Google Cloud Platform 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.
• 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.
• Veeva experience a plus.