Responsibilities:
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 Harmonization 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).
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
Client: AstraZeneca,
Location: Wilmington, DE
-Bachelor’s degree is preferred
- 3-5 years of experience in clinical trials 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
- High ability to manage priorities and Local Study Team expectations
