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AI Summary
The eTMF Specialist is responsible for maintaining the electronic Trial Master File (eTMF), ensuring accurate and timely filing of study documentation, and supporting Document Owners with quality reviews. The role also includes training new team members in documentation management and eTMF filing procedures. Depending on business needs and the eTMF Lead's assessment, the specialist may support one or more eTMF-related activities in compliance with applicable procedures and guidelines.
The role is fully home base in Philippines.
Key Responsibilities:
- Review study documents for quality, completeness, and compliance before filing in the eTMF
- Upload, index, QC, and maintain documentation within the eTMF system
- Act as the main point of contact for study teams regarding document filing and archiving
- Manage both electronic and wet-ink documentation, including scanning, uploading, and archiving when required
- Ensure the eTMF is accurate, up to date, and inspection-ready at all times
- Support eTMF quality control activities, resolve documentation issues, and address Sponsor queries
- Provide regular updates on documentation status to project and study teams
- Maintain training compliance, accurate time tracking, and achievement of assigned KPIs/KQIs
- Support additional documentation management activities as assigned by the eTMF Lead
Requirements:
- College Degree
- Previous experience (at least one year) in the pharmaceutical, biotechnology, CRO industry
- Familiarity with document management systems and electronic databases
- Good knowledge of English (written and speaking)
- Good knowledge and experience with Microsoft Office
- Communication skills
- Ability to multitask, prioritize work and meet deadlines
- Ability to work independently and as part of a team, guaranteeing the security of information
Who we are
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements.
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