Remote eTMF Specialist: Document Control & Training

OPIS s.r.l.; United States; Remote; USD 9,726 - 15,561; Full time

Job summary

OPIS s.r.l. is seeking an eTMF Specialist to maintain the electronic Trial Master File, ensuring accurate and timely filing of study documentation. The role includes supporting document owners with QC, and training new team members in documentation management and eTMF filing procedures.

The position is fully remote with base in the Philippines, and may involve supporting multiple eTMF activities in line with SOPs and guidelines.

Qualifications

• College degree required in a relevant field.
• At least 1 year experience in pharma/biotech/CRO.
• Familiar with document management systems and electronic databases.
• Proficient written and spoken English.
• Proficient in Microsoft Office.
• Strong communication skills.
• Able to multitask, prioritize and meet deadlines.
• Capable of working independently and in a team, ensuring information security.

Responsibilities

• Review study documents for quality, completeness and compliance before filing in the eTMF.
• Upload, index, QC, and maintain documentation in the eTMF system.
• Serve as main contact for study teams on filing and archiving.
• Manage electronic and wet-ink docs, including scanning and archiving as required.
• Ensure eTMF is accurate, up-to-date and inspection-ready.
• Support eTMF quality control activities and resolve issues.
• Provide regular updates on documentation status to project teams.
• Maintain training compliance, time tracking, and KPI/KQI achievement.
• Support additional documentation management activities as assigned by the eTMF Lead.

Skills

English Proficiency

Communication

Multitasking

Prioritization

Teamwork

Info Security

Deadline-driven

Document management

Education

College Degree

Tools

Microsoft Office

Job description

OPIS s.r.l. is seeking an eTMF Specialist to maintain the electronic Trial Master File, ensuring accurate and timely filing of study documentation. The role includes supporting document owners with QC, and training new team members in documentation management and eTMF filing procedures.

The position is fully remote with base in the Philippines, and may involve supporting multiple eTMF activities in line with SOPs and guidelines.