Tilda Research, Inc. is hiring a TMF Specialist to support electronic Trial Master File (eTMF) operations, document quality, completeness and inspection readiness across clinical studies. The role is suitable for professionals with 2–3 years of experience in TMF/eTMF operations within clinical research.
The position focuses on Veeva Vault eTMF, ALCOA+, metadata quality checks, Expected Document List (EDL) management, TMF completeness reviews and inspection readiness.
TMF Specialist Job Overview
| Particulars | Details |
|---|---|
| Company | Tilda Research, Inc. |
| Job Role | TMF Specialist |
| Department | Clinical Research / TMF Operations |
| Experience | 2–3 Years |
| Primary System | Veeva Vault eTMF |
| Industry | Clinical Research / Life Sciences |
| Work Type | Not specified in the provided job details |
| Job Location | Not specified in the provided job details |
About the TMF Specialist Role
The TMF Specialist will be responsible for maintaining eTMF completeness, accuracy and inspection readiness across assigned clinical studies.
The role involves conducting periodic and milestone reviews in Veeva Vault, identifying missing or incorrect documents, checking metadata and ensuring that study documentation complies with applicable quality and regulatory requirements.
The TMF Specialist will also work closely with Study Teams, TMF Leads, Document Owners and other stakeholders to resolve documentation gaps and maintain inspection-ready trial records.
Key Responsibilities
eTMF Reviews & Inspection Readiness
- Perform comprehensive eTMF completeness checks during periodic and milestone reviews.
- Conduct cross-checks and verify document co-dependencies.
- Maintain inspection readiness for assigned clinical studies.
- Identify and resolve missing, incorrect or incomplete documents.
- Update and maintain the Expected Document List (EDL) when requirements change.
Quality, Compliance & Metadata
- Perform ALCOA+ and metadata checks.
- Ensure document accuracy, integrity and compliance with GCP and internal SOPs.
- Validate document types, properties and indexing.
- Check scanning quality against TMF readiness requirements.
- Ensure documents meet applicable TMF reference standards.
Collaboration & Issue Resolution
- Work with Study Teams, TMF Leads, Document Owners and TMF Study Owners.
- Follow up with stakeholders to close documentation gaps and action items within agreed SLAs.
- Escalate risks and issues to the appropriate TMF Operations or leadership teams.
- Communicate document-related queries and provide guidance on corrective actions.
Operations, Training & Process Improvement
- Process TMF documents according to good documentation practices and study priorities.
- Deliver training and office-hour sessions for internal teams.
- Respond to TMF process and system-related questions.
- Contribute to process improvement initiatives and special projects.
- Act as a subject matter expert for TMF processes, systems and tools where required.
Required Qualifications
Candidates should have:
- 2–3 years of experience in TMF/eTMF operations within clinical research.
- Experience working with a CRO, pharmaceutical sponsor or TMF service provider.
- Hands-on experience with Veeva Vault eTMF or a similar eTMF system.
- Experience with document ingestion, indexing, QC and reporting.
- Strong knowledge of:
- ICH-GCP
- ALCOA+
- TMF Reference Model
- Experience conducting completeness reviews.
- Experience managing Expected Document List (EDL) updates.
- Knowledge of maintaining clinical trial inspection readiness.
- Strong attention to detail and organizational skills.
- Good stakeholder communication and issue-escalation skills.
- Ability to manage multiple studies and work within defined SLAs.
Preferred Qualifications
The following experience will be an advantage:
- Experience across Phase I–IV clinical trials.
- Experience working across multiple therapeutic areas.
- Previous experience as a TMF SME or Trainer.
- Experience creating SOPs or work instructions.
- Knowledge of TMF metrics and dashboards.
- Experience with completeness, timeliness and quality reporting.
- Exposure to audit and regulatory inspection support.
- Familiarity with eCTD concepts, QMS and eTMF reporting/BI tools.
Tools & Systems
The primary system for this role is:
- Veeva Vault eTMF
Additional tools and exposure may include:
- Microsoft Excel / Google Sheets
- TMF reporting and BI tools
- QMS
- eCTD concepts
Key Performance Indicators (KPIs)
Performance in the TMF Specialist role may be measured through:
- eTMF completeness percentage
- Document quality error rate
- On-time document processing against SLA
- Aging of open queries and action items
- Findings from internal QC, audits and regulatory inspections
- Training adoption
- Stakeholder satisfaction
About Tilda Research
Tilda Research, Inc. is a clinical research technology company focused on using AI-native tools and AI teammates to support clinical research operations.
The company develops technology intended to help sponsor, CRO and research teams simplify study management, improve data quality, support real-time oversight and reduce administrative bottlenecks in clinical trial execution.
How to Apply
Interested candidates with relevant TMF/eTMF and Veeva Vault experience can apply for the TMF Specialist position through the company’s official recruitment channel.
Candidates should ensure that their resume highlights experience with Veeva Vault eTMF, TMF completeness reviews, EDL management, ALCOA+, ICH-GCP, document QC and inspection readiness.
