Nagadevi Karri
Hyderabad
Summary
Driven by a passion for clinical research and a commitment to excellence. Throughout my journey with esteemed organizations I have significantly enhanced document processing efficiency. My expertise in archiving and coordination has driven successful project completions, showcasing my ability to meet critical milestones with precision and mentoring new joiners, and driving process enhancements. My expertise extends to clinical operations, TMF inspection readiness, regulatory compliance, and cross-functional team leadership. I am dedicated to leveraging my critical thinking and problem-solving abilities to contribute to the advancement of clinical research and ensure the highest standards of quality and compliance.
Overview
7
7
years of professional experience
1
1
Certification
Work History
TMF Lead
OrciMed Life Sciences
10.2025 - Current
- Lead and oversee the setup, maintenance, and closeout of the Trial Master File (TMF) across assigned clinical studies.
- Ensure the TMF is inspection-ready at all times and regulatory compliance of TMF at all times for assigned studies.
- Develop and implement TMF management plans (TMPs) and filing conventions.
- Monitor TMF completeness, timeliness, and quality through periodic QC checks and metrics tracking.
- Supervise and mentor TMF Specialists, Document Coordinators, and Clinical Team members handling TMF activities.
- Provide training and guidance on TMF processes, tools, and regulatory expectations.
- Act as the primary point of contact between study teams, CROs, and sponsors for TMF-related matters.
- Conduct regular TMF health checks and reconciliation (Sponsor vs CRO or eTMF system).
- Identify and resolve gaps, duplicates, or misfiled documents.
- Ensure metadata accuracy and proper document version control.
- Support audits and inspectionsby preparing TMF documentation and addressing findings promptly.
- Collaborate with Clinical Operations, QA, and IT to optimize eTMF systems and workflows.
- Contribute to the development, review, and revision of TMF SOPs, WI, and templates.
- Evaluate and implement best practices and automation tools to improve TMF efficiency and compliance.
- Generate TMF completeness and quality reports for project leadership and sponsors.
- Track KPIs and compliance metricsto ensure timely filing and overall TMF health.
- Present TMF status updates in study team meetings and management reviews.
- Provide TMF access, document retrieval, and evidence of compliance during inspections.
- Lead CAPA (Corrective and Preventive Action) efforts for any TMF-related findings.
Sr. TMF Specialist
OrciMed Life Sciences
05.2025 - 10.2025
- Develop and implement TMF management plans (TMPs) and filing conventions.
- Monitor TMF completeness, timeliness, and quality through periodic QC checks and metrics tracking.
- Supervise and mentor TMF Specialists, Document Coordinators, and Clinical Team members handling TMF activities.
- Provide training and guidance on TMF processes, tools, and regulatory expectations.
- Act as the primary point of contact between study teams, CROs, and sponsors for TMF-related matters.
- Conduct regular TMF health checks and reconciliation (Sponsor vs CRO or eTMF system).
- Identify and resolve gaps, duplicates, or misfiled documents.
- Ensure metadata accuracy and proper document version control.
- Support audits and inspections by preparing TMF documentation and addressing findings promptly.
- Collaborate with Clinical Operations, QA, and IT to optimize eTMF systems and workflows.
- Contribute to the development, review, and revision of TMF SOPs, WI, and templates.
- Evaluate and implement best practices and automation tools to improve TMF efficiency and compliance.
- Generate TMF completeness and quality reports for project leadership and sponsors.
- Track KPIs and compliance metrics to ensure timely filing and overall TMF health.
- Present TMF status updates in study team meetings and management reviews.
- Provide TMF access, document retrieval, and evidence of compliance during inspections.
- Lead CAPA (Corrective and Preventive Action) efforts for any TMF-related findings.
eTMF Specialist
IQVIA, Bangalore
11.2018 - 12.2024
- Process study documentation in accordance with Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines, and study-specific TMF Plans.
- Review of the list of final documents during the File Review preparation stage, a process to catch easily seen subject line discrepancies and duplicates.
- Perform quality review of documents submitted for entry into the TMF, and liaise with project teams to resolve any issues identified.
- Follow up with action owners for open TMF issues.
- Participate in client or internal audits, and document archiving activities as necessary.
- Ensure inspection readiness through a complete, accurate, and readily available Trial Master File.
- Provides process support for TMF creation, maintenance, closure, and archival.
- Work on cross-functional teams, including Project Management, Business Development, Client Services, Development, and IT, on the implementation and management of client projects.
- Provide mentoring and lead the Clinical Document Specialist Team.
- Work on eTMF process improvement, effectiveness, and efficiency in consultation with the Head of Operations.
- Assist in updating and maintaining systems within project timelines, and per project plans.
- Adhere to the PSMT for eTMF document processing, ensuring that it is referenced every time a document is processed.
- Involved in the query resolution process of fellow team members.
- Assigning resources based on the priority of projects.
- Creating reports and dashboards in eTMF resources based on the priority of projects.
- Address gaps in TMF compliance as highlighted by quality metrics and KPIs.
Education
Master of Science - Biotechnology
Reva Institute of Science And Management
Bengaluru, IndiaSkills
- Proficiency in Veeva Vault, Intrinsic CTMS, Pharmaseal CTMS, Trial interactive, Phlex global, and EDC
- Wingspan
- Workflow management
- TMF inspection readiness
- TMF Audit
- Indexing and QC checks
- Multitasking efficiency
- Teamwork orientation
- Trial Management
- Effective Communication
PROJECTS
Studies on the In-vitro Regenerative Response of Santalum Album, IJRD Journal, 4, 3, 03/01/15, Nagadevi K, Ch. Madhavi, Balasubramanian Satyamurthy
Certification
- Clinical Research Training: Good Clinical Practices (BARNET GCP) Training Course, 2018
- Serious Breaches of GCP - MHRA Requirements, 2018
- Fundamental GCP Accreditation Exam (English), 2018
- Expert GCP Accreditation Exam (English), 2018
- GCP Certification Exam-IQVIA_GCP-E6R2_Assessment, 2022
Timeline
TMF Lead
OrciMed Life Sciences
10.2025 - Current
Sr. TMF Specialist
OrciMed Life Sciences
05.2025 - 10.2025
eTMF Specialist
IQVIA, Bangalore
11.2018 - 12.2024
Master of Science - Biotechnology
Reva Institute of Science And Management