eTMF & Regulatory Study Documents Specialist

US Tech Solutions; Wilmington (DE); On-site; USD 70,000 - 95,000; Full time

Job summary

A global staff augmentation firm is seeking a qualified candidate to manage clinical trial documentation and ensure compliance with regulatory standards. The role involves setting up and closing Trial Master Files, supporting study documentation, and working with electronic systems for regulatory submissions. The ideal candidate will have a Bachelor's degree and 3-5 years of relevant experience, with strong organizational skills and the ability to work collaboratively in an international team.

Qualifications

• 3-5 years of experience in clinical trial DOCUMENT MANAGEMENT and regulatory documents.
• Experience with electronic trial master file system(s) including uploading, reviewing, QC, approval of study required documents.

Responsibilities

• Set-up, maintain, and close the local Trial Master File (eTMF) and Investigator Site File.
• Support the production and maintenance of study documents, ensuring compliance with the Client Authoring Guide.
• Contribute to electronic applications/submissions by handling clinical-regulatory documents.
• Maintain tracking information in Client tools like IMPACT and SharePoint.

Skills

Experience with electronic trial master file system(s)

Working knowledge of the Clinical Study Process

Good verbal and written communication

Ability to develop advanced computer skills

Good interpersonal skills

Excellent organization and time management skills

Team oriented and flexible

Education

Bachelor’s degree

Job description

A global staff augmentation firm is seeking a qualified candidate to manage clinical trial documentation and ensure compliance with regulatory standards. The role involves setting up and closing Trial Master Files, supporting study documentation, and working with electronic systems for regulatory submissions. The ideal candidate will have a Bachelor's degree and 3-5 years of relevant experience, with strong organizational skills and the ability to work collaboratively in an international team.