Clinical Research Analyst
Location
Bangalore | India
Job description
TMF Specialist
Responsibilities:
- Receive and process clinical trial documents, ensuring proper filing and indexing.
- Perform quality checks on documents to ensure they meet regulatory requirements and study protocols.
- Maintain and update the TMF according to established guidelines and best practices.
- Track and manage document versions and ensure timely filing of essential documents.
- Respond to requests for documents from internal and external stakeholders.
- Prepare the TMF for inspections and audits.
- Collaborate with cross-functional teams, including clinical research associates, data managers, and regulatory affairs specialists.
- Stay up-to-date on evolving TMF regulations and best practices.
Qualifications:
- Bachelor's degree in life sciences, healthcare administration, or a related field preferred.
- Minimum of 0-2 years of experience in clinical research or document management.
- Strong understanding of Good Clinical Practice (GCP) guidelines and TMF regulations.
- Excellent organizational and time management skills.
- Proficiency in Microsoft Office Suite and document management systems.
- Meticulous attention to detail and accuracy.
- Strong communication and interpersonal skills.
- Ability to work independently and as part of a team.
Interested to apply can share Cv or call/whatsapp to
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