Our client, a global, science-led biopharmaceutical business is seeking a Study Management Specialist to join their growing team in Wilmington, DE for a 1 year contract with potential of extension. This is a great opportunity to work at a household name, get industry best training, and work with state-of-the-art equipment, systems and products.
– Own and maintain quality for the study file as the local study team TMF owner – Responsible for site communications and Vendor Management – Running and analyzing reports from multiple systems, handling 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 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 by handling clinical-regulatory documents according to Submission Ready Standards, supporting effective delivery to regulatory authorities
– Bachelor’s degree is preferred – 3+ years of experience in clinical trials and knowledge of clinical study& regulatory documents – Experience with electronic Trial Master File system(s) including uploading, reviewing, QC, and approval of study required documents. – Working knowledge of the Clinical Study Process and of the ICH/GCP guidelines – Veeva experience a plus