Specialist Study Management

  • Type: Contract
  • Job #38528

Specialist Study Management

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


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Equal Employment Opportunity (EEO) Information

While the position you're applying for may not be for a government role, Astrix is a governmental contractor and, as such, is required to collect certain information in its applicants. Astrix is an Equal Opportunity Employer and does not discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status. Completion of these fields will not affect your opportunity for employment or the terms or conditions of your employment.

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