Vacancy expired!
CLINICAL TRIAL DOCUMENT MANAGEMENT WITH TMF WILMINGTON, DE Onsite. 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 .
- Veeva experience a plus .
- Accountable and inquisitive.
- 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/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 .
- Integrity and high ethical standards .
Vacancy expired!