• , US

Company:  Confidential

Job Title: Sr. Manager, ETMF Management

Job Number: 74048

Location: , US

Job Description

An exciting opportunity awaits for a Trial Master File Manager to oversee TMF activities across our portfolio, reporting to the Director of Clinical Compliance. Responsibilities include managing filing and maintenance activities throughout the lifecycle of clinical trials, supporting both internal teams and CRO partners. The ideal candidate is detail-oriented, adaptable, and solution-oriented.

Responsibilities

* Maintain communication with project teams, staff and vendors. * Support document filing. * Review plans for compliance and oversight. * Perform routine quality checks of uploaded documents. * Respond to management inquiries. * Attend departmental and study meetings as needed. * Run routine reports and monitor completeness. * Provide training to new members if required. * Handle general administrative tasks. * Complete study document-related tasks as needed. * Additional duties as required.

Required Skills

* Life sciences degree or relevant allied health certification. * 3-5 years of clinical trial experience.  * Effective and timely communication abilities. * Knowledge of GCP and regulatory requirements, with understanding of clinical research documents. * Proficient in MS Office tools like Outlook, Word, Excel, PowerPoint, and SharePoint.

Application Deadline: 2024-03-18

 

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