TMF Classifier II | Full-Time | Bangalore, India (Hybrid)
Experience Required: 1–2 years
Job Description:
We are seeking a detail-oriented TMF Classifier II to support electronic Trial Master File (eTMF) management and document classification activities in a hybrid work environment. This role is critical in maintaining audit-ready TMF systems by ensuring accurate document classification, quality control, and compliance with global regulatory standards.
Key Responsibilities:
Manage document classification activities within Smart Inbox and perform ARC reviews, including document deletion where applicable.
Maintain electronic Trial Master Files (eTMF) across trial, country, and site levels in accordance with company and sponsor requirements.
Conduct visual quality checks on documents to ensure clarity, accuracy, and completeness before finalization.
Perform audit readiness checks on all uploaded documents, ensuring correct indexing and contextual accuracy.
Process, track, and manage essential study documents throughout all phases of clinical trials.
Ensure compliance with ICH-GCP guidelines, regulatory requirements, and standard operating procedures (SOPs).
Identify and resolve operational issues related to TMF processes and documentation.
Support preparation for QA and sponsor audits, including implementation of corrective and preventive actions (CAPA).
Participate in internal and external audits as required.
Collaborate with cross-functional teams to ensure efficient TMF management and client satisfaction.
Contribute to process improvement initiatives to enhance quality, productivity, and operational efficiency.
Provide training and mentoring to team members as needed.
Attend study team meetings and support ongoing clinical operations.
Qualifications & Experience:
Bachelor’s degree in Life Sciences, Pharmacy, or Business-related field.
1–2 years of experience in clinical research, TMF management, or document management roles.
Strong understanding of ICH-GCP guidelines and regulatory documentation requirements.
Experience working with eTMF systems and clinical electronic platforms is preferred.
Proficiency in Microsoft Office, web-based applications, and Adobe Acrobat.
Strong attention to detail, organizational, and communication skills.
Ability to manage multiple tasks and maintain high-quality standards under deadlines.
Preferred Qualifications:
Master’s degree in Life Sciences or Business-related field.
Experience with clinical trial electronic systems and document management tools.
Location: Bangalore, India (Hybrid Work Model)
Why Join Us:
Work on global clinical trials with a focus on regulatory compliance and quality documentation.
Gain hands-on experience with advanced eTMF systems and clinical processes.
Collaborate with cross-functional teams in a dynamic and professional environment.
Access opportunities for continuous learning, skill development, and career growth in clinical research.
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