Trial Documentation Specialist

Wilmington, DE 19805

Posted: 08/30/2018 Industry: Other Area(s) Job Number: 31200

Trial Documentation Specialist


Ideal Candidate Profile: 
- 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 

Responsibilities: 
- 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   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  tracking and communication tools (e.g. IMPACT, SharePoint etc) and support others in the usage of these systems 

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


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