Are you an experienced Trial Master File (TMF) professional looking to work on global clinical research projects? Do you have hands-on experience with eTMF systems like Veeva Vault TMF and prefer flexible working options?
If yes, this is an exciting opportunity to grow your career with OrciMed Life Sciences, which is currently hiring TMF Specialists and Senior TMF Specialists for UK and USA shift roles. 🚀📁
With multiple openings and office, hybrid, and remote work options, this role is ideal for immediate joiners seeking long-term growth in clinical research documentation.
🏢 About OrciMed Life Sciences
OrciMed Life Sciences is a growing organization in the clinical research and life sciences domain, supporting global sponsors and CROs with clinical operations, documentation, and regulatory services.
The company is known for:
- Strong quality-driven culture
- Focus on inspection-ready TMF management
- Exposure to global clinical trial standards
- Use of advanced electronic TMF platforms
Employees at OrciMed work closely with international teams and gain hands-on experience with global regulatory expectations and best practices. 🌍📊
🕒 Work Shift & Flexibility
One of the biggest advantages of this opportunity is its flexibility:
Shift:
- UK Shift / USA Shift 🌙🌎
Work Mode:
- Office-based
- Hybrid
- Remote
This makes the role suitable for professionals comfortable working with global stakeholders and international timelines.
📌 Open Positions
🔹 TMF Specialist
- Experience Required: Minimum 2+ years in TMF management
🔹 Senior TMF Specialist
- Experience Required: Minimum 4+ years in TMF management
📢 Multiple positions available
🚀 Immediate joiners preferred
🧠 Role Overview: TMF & Senior TMF Specialist
In this role, you will be responsible for maintaining a complete, accurate, and inspection-ready Trial Master File throughout the clinical trial lifecycle.
Your work will directly impact:
- Regulatory compliance
- Audit and inspection readiness
- Overall trial quality and documentation excellence ✔️
You’ll collaborate closely with clinical operations, safety, quality, and regulatory teams to ensure TMF compliance with SOPs and global regulations.
📝 Key Responsibilities
📁 TMF Management
- Maintain TMFs in compliance with ICH-GCP and internal SOPs
- Ensure TMF completeness, accuracy, and real-time inspection readiness
- Perform TMF quality checks, reconciliations, and periodic reviews
💻 eTMF Systems
- Hands-on work with Veeva Vault TMF
- Upload, index, and classify TMF documents correctly
- Support TMF migrations, system audits, and ongoing reviews
⏱️ Task & Timeline Management
- Manage multiple studies simultaneously
- Prioritize tasks under tight timelines
- Ensure timely filing of essential documents
🔐 Compliance & Safety Documentation
- Handle safety reporting documentation
- Support filing of safety reports and correspondence
- Argus uploads experience is a strong advantage
🤝 Cross-Functional Collaboration
- Coordinate with clinical operations, safety, and quality teams
- Communicate with internal and external stakeholders
- Support regulatory inspections and audits
🎓 Eligibility Criteria
🎓 Education
- Bachelor’s degree in Life Sciences, Pharmacy, Clinical Research, or a related field
💼 Experience
- Strong hands-on experience with TMF processes and eTMF systems
- Prior experience in clinical trials or CRO environments
- Exposure to PV documentation preferred (not mandatory)
🌟 Skills & Competencies
Successful candidates should have:
- Excellent written and verbal communication skills 🗣️✍️
- Strong organizational and documentation abilities
- High attention to detail and quality focus
- Ability to work independently in remote or hybrid setups
- Confidence handling global teams and timelines
- Good understanding of regulatory guidelines and TMF structures
🚀 Why Join OrciMed Life Sciences?
Joining OrciMed as a TMF professional offers:
✅ Exposure to global clinical trials
✅ Flexible work models (office / hybrid / remote)
✅ UK & USA shift opportunities with global collaboration
✅ Career growth into lead or management TMF roles
✅ Stable, quality-focused work environment
TMF roles are increasingly critical in today’s clinical research ecosystem, making this an excellent opportunity for long-term career advancement in Clinical Operations and Regulatory Compliance. 📈✨
📧 How to Apply
Interested and eligible candidates can apply by sending their updated CV to:
📩 careers@orcimedlifesciences.com
📌 Make sure your resume clearly highlights:
- TMF/eTMF platform experience
- Total years of TMF work
- Experience with Veeva Vault TMF (if applicable)
🧾 Final Note
If you are passionate about clinical documentation, TMF quality, and regulatory compliance, the TMF Specialist & Senior TMF Specialist roles at OrciMed Life Sciences offer a rewarding and future-proof career path.
📂🌟 Apply now and take the next step in your TMF career!
