CuRRENT oPPORTUNITIES

---

Location: Remote (East Coast USA preferred - EST/CST time zones)
Client: Leading Medical Device Company

Position ID: 20251118_MD_G
Employment Type: Part-time, up to 30 hours/week

Rate: 1099 only, $65-$85/hr, based on experience and client approval

Position Overview:
We're seeking an experienced Trial Master File (TMF) Document Manager to join our client's Clinical Operations team. This role is critical to ensuring regulatory compliance and data integrity across all clinical investigations.

Key Responsibilities:

• Manage and maintain the electronic Trial Master File (eTMF) system for all active clinical investigations in compliance with ICH GCP, FDA regulations (21 CFR Part 11, 21 CFR Part 812), ISO 14155, and other applicable standards
• Oversee document collection, review, filing, and archival of essential documents per TMF Reference Model (DIA TMF Model)
• Ensure completeness, accuracy, and inspection-readiness of all TMF documentation
• Develop and maintain TMF procedures, work instructions, and training materials
• Conduct regular TMF quality control reviews and generate metrics/reports on TMF health and completeness
• Lead TMF readiness activities for regulatory inspections and audits
• Train and support cross-functional team members on eTMF system use and TMF best practices

Required Qualifications:

• Minimum 5 years of hands-on experience managing Trial Master Files for clinical trials (medical device, pharmaceutical, or biotech)
• Strong working knowledge of ICH GCP, FDA 21 CFR Part 11, FDA 21 CFR Part 812, ISO 14155, and TMF regulatory requirements
• Experience with electronic Trial Master File (eTMF) systems required
• Thorough understanding of DIA TMF Reference Model and essential documents
• Experience preparing TMFs for regulatory inspections and audits
• Strong organizational skills with exceptional attention to detail
• Excellent written and verbal communication skills

Preferred Qualifications:

• Experience with MasterControl eTMF system highly preferred
• Medical device clinical trial experience preferred
• Experience with ISO 14155 compliance for medical device investigations
• ACRP or SoCRA certification
• Bachelor's degree in life sciences, healthcare administration, or related field

To Apply: Please send your resume and cover letter to jobs@cascades-consulting.com with "TMF Document Manager" in the subject line.

 We're always interested in connecting with talented professionals in clinical research, regulatory affairs, quality assurance, and related fields. Even if you don't see a current opening that matches your background, we encourage you to reach out. Send your resume to jobs@cascades-consulting.com, and we'll keep you in mind for future opportunities that align with your skills and career goals. 

Cascades Consulting and our client partners are equal opportunity employers. We celebrate diversity and are committed to creating inclusive environments for all candidates and employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.