Alimentiv is hiring a TMF Coordinator for its Clinical Services and TMF Operations team. This is an excellent opportunity for Life Sciences and clinical research professionals with experience in Trial Master File (TMF) management, eTMF systems, clinical trial documentation, and regulatory compliance.
The selected candidate will be responsible for maintaining the quality, completeness, accuracy, and compliance of TMF documentation. The role involves working closely with clinical study teams and cross-functional stakeholders to ensure Trial Master File records remain complete, inspection-ready, and aligned with global regulatory and company requirements.
Candidates with 1โ3 years of experience in clinical trials, TMF management, document management, or eTMF operations are encouraged to apply.
TMF Coordinator Job Responsibilities
TMF Oversight and Compliance
As a TMF Coordinator at Alimentiv, you will:
- Maintain in-depth knowledge of paper and electronic TMF structures.
- Ensure compliance with ICH-GCP, FDA, and EMA regulations.
- Apply ALCOA+ data integrity principles.
- Support inspection readiness and audit activities.
- Ensure proper management of essential clinical trial documentation.
- Maintain accurate, complete, and compliant Trial Master File records.
Systems and Document Management
Key responsibilities include:
- Accurately file, classify, and index documents within the TMF.
- Follow document naming conventions and version control procedures.
- Maintain consistency and compliance within TMF structures.
- Work with electronic TMF and document management systems.
- Utilize eTMF platforms such as Veeva Vault, Phlexglobal, and Trial Interactive.
- Use Microsoft Office applications, including Excel, Word, and SharePoint, for reporting and coordination.
TMF Quality Control Responsibilities
The TMF Coordinator will:
- Perform quality control checks on TMF documents and metadata.
- Identify missing, incomplete, duplicate, or inconsistent records.
- Resolve documentation gaps and TMF discrepancies.
- Ensure the accuracy, completeness, and timeliness of TMF content.
- Support TMF health checks.
- Assist with TMF reporting and quality metrics.
Issue Resolution and Process Improvement
The selected candidate will:
- Investigate and resolve TMF gaps and discrepancies.
- Troubleshoot document filing and system-related issues.
- Support root cause analysis for quality issues.
- Contribute to process improvement initiatives.
- Support standardization of TMF processes.
- Help improve the overall efficiency and quality of TMF Operations.
Stakeholder Engagement
The TMF Coordinator will work closely with clinical teams and stakeholders to:
- Collaborate with study teams and cross-functional departments.
- Proactively follow up on outstanding documentation.
- Provide guidance on TMF requirements and processes.
- Support audit and inspection readiness activities.
- Communicate effectively with internal stakeholders.
Qualifications Required
Candidates applying for the Alimentiv TMF Coordinator job should have:
- A Bachelor’s degree in Life Sciences or a related field preferred.
- 1โ3 years of experience in clinical trials and TMF management.
- Working knowledge of eTMF platforms and regulatory requirements.
- Understanding of clinical trial record management.
- Knowledge of clinical documentation and quality standards.
- Experience with document management systems.
- Ability to work effectively in a remote or hybrid work environment.
Eligible Educational Qualifications
Candidates from the following educational backgrounds may be suitable:
B.Pharm, M.Pharm, Pharm.D, B.Sc Life Sciences, M.Sc Life Sciences, Biotechnology, Clinical Research, Biochemistry, Microbiology, Biology, or other related Life Sciences degrees.
Required Skills
Candidates should demonstrate knowledge or experience in:
- Trial Master File (TMF)
- TMF Management
- eTMF Operations
- Clinical Trial Documentation
- Clinical Research
- Veeva Vault
- Phlexglobal
- Trial Interactive
- Document Management
- Quality Control
- ICH-GCP
- FDA Regulations
- EMA Regulations
- ALCOA+ Principles
- Microsoft Excel
- Microsoft Word
- SharePoint
- Regulatory Compliance
Experience Required
1โ3 Years
Relevant experience may include:
- TMF Management
- TMF Operations
- eTMF Management
- Clinical Operations
- Clinical Trial Management
- Clinical Document Management
- Clinical Research Coordination
- Document Quality Control
- Regulatory Documentation
Job Locations
This position is cross-listed across multiple locations.
India
- Ahmedabad
- Bangalore
- Delhi
- Mumbai
Brazil
- Brasilia
- Rio de Janeiro
- Sao Paulo
- Salvador
Work Mode: Hybrid
Salary and Benefits
The advertised compensation for this position is:
$42,000โ$70,000 per year + Bonus
Compensation may vary depending on:
- Job location
- Country
- Candidate experience
- Qualifications
- Local compensation policies
- Employment arrangements
For India-based candidates, the actual salary package may differ from the globally advertised compensation range.
Benefits of Working in TMF Operations
This opportunity provides professionals with exposure to:
- Global clinical trials
- TMF Operations
- Electronic TMF systems
- Clinical documentation management
- Regulatory compliance
- Audit and inspection readiness
- Cross-functional clinical teams
- International clinical research processes
Why Choose a Career in TMF Management?
The Trial Master File (TMF) is a critical component of clinical research. It contains essential documents that demonstrate whether a clinical trial has been conducted according to the protocol, regulatory requirements, and Good Clinical Practice standards.
A career as a TMF Coordinator can help professionals build expertise in:
- Clinical Operations
- Clinical Trial Documentation
- Regulatory Compliance
- Quality Management
- eTMF Systems
- Inspection Readiness
- Audit Support
- Clinical Research Operations
Professionals can potentially progress into roles such as:
- TMF Specialist
- Senior TMF Specialist
- TMF Lead
- Clinical Trial Associate
- Clinical Operations Specialist
- Clinical Project Coordinator
- Clinical Quality Specialist
How to Apply
