The clinical research industry in India continues to create exciting opportunities for professionals who want to build a stable and rewarding career in the pharmaceutical and CRO sector. One such opportunity is now open with Indero, formerly known as Innovaderm. The company is hiring for the position of TMF Document Coordinator I for a remote/home-based role in India.
If you have experience in clinical research, TMF management, documentation review, or regulatory compliance, this could be an excellent opportunity to work with an international organization while enjoying the flexibility of working from home. 🌍💻
📌 About Indero
Indero is a global Clinical Research Organization (CRO) known for supporting biotechnology and pharmaceutical companies in clinical trial management and research operations. The organization focuses on innovation, collaboration, reliability, and quality-driven clinical research solutions.
The company offers a professional work culture, growth opportunities, and continuous learning support for employees working across different regions worldwide.
💼 Job Role: TMF Document Coordinator I
The selected candidate will support the management and maintenance of the Trial Master File (TMF) throughout the clinical trial lifecycle.
This role is ideal for candidates who have strong attention to detail, good documentation skills, and experience in clinical trial documentation processes.
📍 Job Location
Remote / Home-Based in India 🇮🇳
🕒 Job Type
Permanent Full-Time Position
🌐 Work Mode
Work From Home (Remote)
📖 What is a TMF Document Coordinator?
A TMF (Trial Master File) Document Coordinator is responsible for ensuring that all essential clinical trial documents are properly reviewed, organized, classified, and maintained according to regulatory standards.
The TMF is one of the most critical components of clinical research because it helps demonstrate that the clinical trial was conducted according to:
- ICH-GCP Guidelines
- Regulatory Requirements
- Sponsor Expectations
- FDA and Health Authority Standards
Professionals in this role help maintain compliance and support inspection readiness during clinical trials. 📂✅
🧾 Key Responsibilities
The TMF Document Coordinator I at Indero will perform several important activities related to TMF management and quality review.
📌 Major Responsibilities Include:
✅ Reviewing TMF Records
- Review submitted TMF records for completeness and quality
- Ensure documents meet study-specific requirements before approval
✅ Metadata Classification
- Assign proper classifications and metadata to clinical trial records
✅ Quality Control Activities
- Identify documentation issues before approval
- Raise queries to document submitters when corrections are needed
✅ TMF Quality Review Support
- Participate in TMF quality review activities
- Resolve assigned findings within timelines
✅ Study Milestone Tracking
- Assist with maintaining expected document lists and study milestones
✅ Metrics and Reporting
- Support the TMF Project Lead in preparing monthly TMF reports and metrics
✅ Team Collaboration
- Work closely with clinical project teams to resolve TMF-related issues
✅ Meeting Participation
- Attend internal TMF meetings and provide status updates regarding documentation and pending queries
🎓 Educational Qualification
Candidates applying for this position should have:
- College Degree in Life Sciences or related field
Preferred Educational Backgrounds:
- B.Pharm
- M.Pharm
- BSc Life Sciences
- MSc Life Sciences
- Biotechnology
- Clinical Research
🧠 Required Skills and Experience
To succeed in this role, candidates should possess a combination of clinical research knowledge and documentation management skills.
📌 Preferred Skills:
- Experience in clinical research, pharmaceutical, biotechnology, or CRO industry
- Understanding of TMF processes
- Knowledge of ICH-GCP guidelines
- Familiarity with FDA regulations and compliance standards
- Strong organizational abilities
- Attention to detail and accuracy
- Ability to handle multiple assignments simultaneously
- Good communication skills in English
- Microsoft Word and Excel proficiency
🌟 Why This Opportunity is Attractive
Remote clinical research opportunities are becoming increasingly popular in India. This role offers several advantages for professionals looking for flexibility and international exposure.
🎯 Benefits of This Role
🏠 Work From Home Opportunity
Candidates can work remotely from India without relocating.
📚 Continuous Learning
Indero provides ongoing learning and professional development opportunities.
🌍 International Exposure
Employees get exposure to global clinical trial documentation processes.
📈 Career Growth
TMF management is a growing domain within clinical operations and regulatory compliance.
🤝 Collaborative Work Culture
The company promotes teamwork, innovation, and employee support.
👩💻 Who Should Apply?
This opportunity may be suitable for:
- Clinical Research Coordinators
- TMF Specialists
- Clinical Trial Assistants
- Regulatory Documentation Professionals
- Freshers with relevant internships in clinical research
- Candidates with CRO experience
- Life science graduates interested in remote clinical operations roles
⏰ Important Work Schedule Information
Although this is a remote role, candidates should note:
⚠️ Some meetings may be scheduled outside regular business hours, mainly during evening hours, to coordinate with international teams.
🚀 Career Scope in TMF Management
TMF management has become one of the fastest-growing areas in clinical research and regulatory operations. Companies increasingly rely on skilled professionals who can maintain inspection-ready documentation throughout the trial process.
Professionals with TMF experience can later grow into roles such as:
- TMF Specialist
- Senior TMF Coordinator
- Clinical Trial Associate
- Clinical Operations Specialist
- Regulatory Affairs Associate
- Quality Assurance Associate
This makes the role a strong long-term career option in the pharmaceutical and CRO industry. 📊
🔗 How to Apply
📢 Final Thoughts
The Remote TMF Document Coordinator I opportunity at Indero offers a strong platform for clinical research professionals seeking international exposure, remote work flexibility, and career growth in TMF and clinical operations.
As the pharmaceutical and biotechnology industries continue expanding globally, professionals with expertise in clinical documentation and compliance are becoming increasingly valuable. Candidates with strong organizational skills and attention to detail should definitely consider applying for this opportunity. 🌟
