Indero is hiring for a TMF Document Coordinator I position in India. This is a permanent, home-based opportunity for candidates interested in clinical research, Trial Master File (TMF) management, clinical trial documentation, and pharmaceutical/CRO operations.
The TMF Document Coordinator I will support the maintenance of a Sponsor’s Trial Master File throughout the clinical trial lifecycle. The position involves reviewing and processing TMF records through quality-control workflows to ensure documentation meets applicable quality, compliance, and regulatory requirements.
Candidates with a college degree and experience in the pharmaceutical, biotechnology, or CRO industry, along with knowledge of Good Clinical Practice (GCP) and relevant FDA and Health Canada regulations/guidelines, can consider this opportunity.
About Indero
Indero is a global clinical research organization specializing in dermatology and rheumatology. Formerly known as Innovaderm, the organization has more than two decades of experience in clinical research and trial delivery.
Indero provides clinical research capabilities spanning protocol design, patient recruitment, trial monitoring, biometrics, and other services supporting biotechnology and pharmaceutical sponsors.
TMF Document Coordinator I – Job Responsibilities
The selected candidate will support Trial Master File activities and collaborate with clinical research project teams.
Key responsibilities include:
- Review TMF records for completeness, accuracy, and quality before approval.
- Classify TMF records according to the appropriate record type.
- Assign suitable metadata to clinical trial documents.
- Identify documentation quality issues during the review process.
- Raise pre-approval queries when information or documentation requires clarification.
- Coordinate with document submitters to resolve queries within established timelines.
- Participate in TMF quality reviews.
- Address assigned TMF findings promptly.
- Assist with maintaining study milestones and Expected Document Lists.
- Support the TMF Project Lead with monthly TMF metrics and reports.
- Attend internal TMF Focus meetings.
- Provide updates regarding TMF status, outstanding queries, and documentation issues.
- Work collaboratively with project team members to resolve issues affecting TMF records.
- Follow study-specific guidelines, company SOPs, GCP requirements, and applicable regulatory expectations.
Eligibility Criteria
Candidates applying for the TMF Document Coordinator I job at Indero should meet the following requirements:
Educational Qualification
- College degree is required.
Industry Experience
Candidates should have experience in clinical research within one or more of the following sectors:
- Pharmaceutical industry
- Biotechnology
- Contract Research Organization (CRO)
- Clinical research
Technical Skills
Applicants should have:
- Computer proficiency
- Working knowledge of Microsoft Word
- Working knowledge of Microsoft Excel
- Ability to work with clinical trial documentation and electronic records
Knowledge of GCP and Regulations
The role requires good knowledge of Good Clinical Practice (GCP) and applicable Health Canada and FDA regulations/guidelines.
Soft Skills
Indero is looking for candidates with:
- Strong attention to detail
- High accuracy
- Good organizational skills
- Ability to manage multiple assignments
- Ability to meet deadlines and established objectives
- Adaptability
- Ability to work effectively in a multitasking environment
- Intermediate English proficiency
Key Skills for a TMF Document Coordinator
Candidates preparing for a TMF Document Coordinator career should be familiar with areas such as:
Trial Master File (TMF), TMF quality control, clinical trial documentation, document review, metadata management, document classification, GCP, clinical research, SOP compliance, FDA regulations, Health Canada regulations, TMF metrics, Expected Document Lists, clinical trial milestones, and quality review workflows.
Experience with clinical documentation and strong attention to detail can be particularly relevant for this type of position.
Benefits and Work Environment
According to the job description, Indero offers the following benefits for this position:
- Flexible work schedule
- Permanent full-time employment
- Home-based work in India
- Ongoing learning and development
- Opportunities for professional advancement
- Collaborative work environment
The position is home-based in India. Candidates should note that some meetings may take place outside regular business hours, primarily during the evening.
Who Can Apply?
This TMF Document Coordinator I India job may be relevant for professionals who have a background in clinical research, pharmaceutical operations, biotechnology, or CRO environments.
Candidates who have worked with clinical trial documents, quality-control processes, GCP requirements, or regulatory documentation may find their experience relevant to the position.
Fresh graduates should carefully review the experience requirement because the job description specifies experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.
How to Apply
