Klinera Hiring eTMF Specialist Job in Mumbai for clinical operations, Veeva eTMF management, compliance, and documentation professionals.
Introduction
Klinera is inviting applications for experienced eTMF Specialist professionals in Mumbai for its Clinical Operations and TMF Management division. This opportunity is ideal for candidates searching for Regulatory Affairs Jobs, Clinical Research Jobs, Pharma Jobs 2026, and Latest Pharma Jobs in India. Professionals with expertise in Veeva eTMF systems, TMF quality review, ALCOA+ principles, and inspection readiness can apply for this exciting opening. The pharmaceutical and biotechnology industry continues to create high demand for skilled TMF professionals capable of handling global clinical trial documentation and compliance activities. Candidates with CRO, pharmaceutical, or biotechnology experience are strongly encouraged to apply.
About Company
Klinera is a clinical research and healthcare solutions company focused on supporting pharmaceutical, biotechnology, and healthcare organizations through advanced clinical operations and data-driven solutions. The company specializes in clinical research support services, regulatory compliance management, clinical documentation handling, and digital healthcare technologies.
Klinera works with global healthcare organizations to improve operational efficiency, regulatory readiness, and clinical trial management processes. Its expertise includes TMF management, clinical data systems, digital healthcare transformation, and clinical operations support. The organization follows international quality standards and regulatory frameworks such as ICH-GCP guidelines and global clinical documentation practices.
With growing operations in India and international markets, Klinera provides career opportunities for professionals in clinical research, pharmacovigilance, TMF management, regulatory operations, and healthcare technology services. The company focuses on innovation, compliance excellence, and efficient clinical trial execution across multiple therapeutic segments.
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Job Details / Job Summary
| Particulars | Details |
|---|---|
| Company Name | Klinera |
| Job Role | eTMF Specialist |
| Department | TMF / Clinical Operations |
| Qualification Required | B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Life Sciences |
| Experience Required | 4+ Years |
| Salary Package | ₹6 LPA – ₹12 LPA (Expected) |
| Job Location | Mumbai |
| Employment Type | Full-Time |
| Industry Type | Pharmaceutical / Biotechnology / CRO |
| Shift Timing | General Shift |
| Gender Eligibility | Male & Female |
| Application Mode | Email Application |
| Selection Process | Resume Screening, Technical Interview, HR Discussion |
| Skills Required | Veeva eTMF, ALCOA+, TMF Review, GDP, ICH-GCP |
| Official Notification Status | Verified Job |
| Application Last Date | Apply As Soon As Possible |
Eligibility Criteria
- Candidates should possess B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, or equivalent Life Sciences qualification.
- Applicants must have a minimum of 4+ years of TMF or records management experience.
- Minimum 3+ years of Veeva eTMF experience is preferred.
- Experience in pharmaceutical companies, biotechnology firms, or CRO organizations is required.
- Strong understanding of TMF Reference Model and ICH-GCP guidelines is essential.
- Knowledge of ALCOA++ principles and Good Documentation Practices (GDP) is mandatory.
- Candidates must possess excellent communication and stakeholder management skills.
- Ability to manage multiple deliverables within strict timelines is preferred.
Required Skills
- Expertise in Veeva Systems eTMF
- TMF Quality Control and Review
- Clinical Trial Documentation Management
- Inspection Readiness Activities
- ALCOA+ and ALCOA++ Compliance
- TMF Reconciliation and Maintenance
- Knowledge of ICH-GCP Guidelines
- Good Documentation Practices (GDP)
- Clinical Operations Coordination
- Regulatory Compliance Management
- Issue Resolution and Problem-Solving Skills
- Strong Analytical and Reporting Abilities
Roles and Responsibilities
TMF Management Responsibilities
- Support Trial Master File setup, maintenance, and archival activities.
- Ensure TMF completeness and inspection readiness throughout the study lifecycle.
- Perform TMF document filing and reconciliation activities.
- Maintain accurate clinical trial documentation according to sponsor requirements.
- Coordinate TMF closeout activities for completed studies.
Quality Review and Compliance Responsibilities
- Conduct ALCOA+ quality control reviews of TMF documents.
- Perform completeness reviews against Expected Document Lists.
- Identify TMF quality issues and support corrective actions.
- Ensure compliance with global regulatory and sponsor requirements.
- Support audit and inspection readiness initiatives.
Clinical Operations Support
- Generate TMF health metrics and compliance reports.
- Support interim TMF review activities.
- Collaborate with cross-functional clinical development teams.
- Assist in clinical documentation planning and execution.
- Maintain effective communication with internal and external stakeholders.
Salary Details
Klinera offers competitive salary packages for experienced TMF professionals based on industry standards and technical expertise. Candidates selected for the eTMF Specialist role may receive an expected salary package ranging between ₹6 LPA and ₹12 LPA. Compensation may vary depending on total TMF experience, Veeva eTMF expertise, inspection readiness exposure, and previous experience in pharmaceutical companies or CRO organizations. Additional growth opportunities and professional development exposure are also offered.
Selection Process
The Klinera hiring process generally includes the following stages:
- Resume Screening
HR and clinical operations teams evaluate candidate profiles and experience. - Technical Evaluation
Candidates are assessed based on TMF management, Veeva eTMF, and compliance knowledge. - Technical Interview
Shortlisted applicants attend interviews focused on clinical documentation and regulatory practices. - HR Discussion
Salary expectations, notice period, and employment terms are discussed. - Final Selection
Selected candidates receive official communication from the company.
Why Join Klinera?
- Opportunity to work on global clinical research projects
- Exposure to advanced Veeva eTMF systems
- Career growth in Clinical Research Jobs and Pharmacovigilance Jobs
- Experience with inspection readiness and regulatory compliance
- Work with cross-functional clinical operations teams
- Professional growth in TMF and clinical documentation management
- Exposure to international clinical trial standards and practices
How to Apply
Interested candidates can send their updated resume through email with the following details:
- Current CTC
- Expected CTC
- Notice Period
- Experience in Veeva – Yes/No
- Experience in ALCOA – Yes/No
Apply via Email:
Candidates should attach their updated resume and mention the applied position clearly in the email subject line.
Frequently Asked Questions
1. What qualifications are required for Klinera eTMF Specialist Jobs?
Candidates with B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, or Life Sciences qualifications can apply.
2. Can freshers apply for this eTMF Specialist role?
No, candidates must have a minimum of 4+ years of TMF or records management experience.
3. What is the expected salary for Klinera eTMF Specialist Jobs?
The expected salary range is approximately ₹6 LPA to ₹12 LPA depending on experience and expertise.
4. How can candidates apply for this Clinical Research Job?
Interested applicants can apply by sending their updated resume to the official company email address.