Nagadevi Karri
Hyderabad
Summary
Experienced Clinical Research professional with over 7+years of expertise in Trial Master File(TMF) Management, clinical operations support, and regulatory compliance within global pharmaceutical and CRO environments.
Currently serving as TMF Lead at Orcimed Lifesciences with extensive experience in Veeva Vault, CTMS, Trial Interactive and study start-up systems. Proven ability to deliver inspection ready TMFs aligned with ICH-GCP and ALCOA principles.
Overview
12
12
years of professional experience
Work History
TMF Lead
Orcimed Life Sciences
Hyderabad
05.2025 - Current
- Supervise and direct setup, maintenance, and decommissioning of trial master file across designated clinical studies.
- Oversaw site binders and ISF across all study sites to ensure consistency, accuracy, and completeness.
- Ensure inspection-ready status of TMF while guaranteeing regulatory compliance across assigned studies.
- Develop and implement comprehensive TMF management plans to enhance regulatory compliance and filing efficiency.
- Oversee TMF completeness, timeliness, and quality through systematic QC checks and meticulous metrics tracking.
- Supervise and mentor TMF specialists, document coordinators, and clinical team members to enhance their competency in managing TMF activities.
- Facilitated training on TMF processes, tools, and regulatory expectations to enhance team compliance and efficiency.
- Facilitates communication between study teams, CROs, and sponsors regarding TMF-related matters.
- Conduct regular TMF health checks and reconcile discrepancies between sponsor and CRO or eTMF systems.
- Identified and resolved gaps, duplicates, or misfiled documents to enhance operational efficiency.
- Ensure metadata accuracy and maintain proper document version control.
- Facilitated support for audits and inspections by preparing TMF documentation and addressing findings promptly.
- Optimised collaboration with clinical operations, QA, and IT to enhance eTMF systems and workflows.
- Contributed to the development and revision of TMF SOPs, work instructions, and templates to enhance operational efficiency.
- Evaluate and implement best practices and automation tools to enhance TMF efficiency and ensure compliance.
- Compile tmf completeness and quality reports to provide strategic insights to project leadership and sponsors.
- Monitored KPIs and compliance metrics to ensure timely filing and optimise overall TMF health.
- Facilitate comprehensive TMF status updates during study team meetings and management reviews.
- Facilitated retrieval of TMF access documents and ensured evidence of compliance during inspections.
- Led corrective and preventive action efforts for TMF-related findings.
ETMF Specialist
IQVIA, Bangalore
11.2018 - 12.2024
- Executed process study documentation in accordance with standard operating procedures, work instructions, GCP ICH guidelines, and study-specific TMF plans.
- Reviewed final documents during file review preparation stage to ensure accuracy and completeness.
- Conduct quality reviews of documents submitted for entry into the TMF while collaborating with project teams to resolve identified issues.
- Facilitated timely follow-up with action owners to resolve open TMF issues.
- Conduct audits and document archiving activities to enhance compliance and organisation.
- Ensure inspection readiness by managing a complete and accurate trial master file.
- Facilitated creation, maintenance, closure, and archival of TMF to ensure compliance and operational efficiency.
- Assisted teams in executing client projects across project management, business development, and IT.
- Supported cross-functional collaboration to ensure effective client services delivery.
Contributed to project implementation and management activities. - Mentored and led clinical document specialist team to enhance document quality and compliance standards.
- Optimised ETMF processes in collaboration with head of operations to enhance overall effectiveness.
- Optimised and maintained systems within project timelines and according to project plans.
- Ensure adherence to PSMT for ETMF document processing whenever documents are handled.
- 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.
Project Co-Ordinator
Cenveo Publishers
Bangalore
03.2016 - 11.2018
- Managed authors' master data and clinical records to ensure accuracy and consistency.
- Assisted in communication with authors and customers.
Tracked priority articles to ensure timely updates.
Reviewed scientific papers for relevance and clarity. - Finalised research articles to ensure high-quality standards and accuracy for customer delivery.
- Contributed to over 50 types of scientific journals by managing editorial processes and ensuring adherence to publication standards.
- Finalised scientific article pages using Adobe Reader and Acrobat Professional to ensure precision and clarity.
- Assigned articles to customers, ensuring adherence to guidelines and expectations.
- Assisted with addressing weekly issues and submitting queries.
Supported the resolution of client inquiries regarding database information.
Facilitated communication between teams to improve issue tracking.
Process associate
Infocon International Ltd
Bangalore
12.2013 - 10.2015
- While working with the SciVal Analytics team, I collaborated on data analyses and the refinement of researcher profiles.
- Worked on clinical and life sciences master data management.
- Maintaining 'SciVal Expert's' profile in terms of expertise profiling and research networking tools makes it easy for researchers, administrators, managers, and senior leadership to find experts, and enable collaboration within their institution and across organisations.
- Analysing the author's scientific papers.
- Maintaining data and preparing scientific documents.
- Maintaining the database at quarterly intervals, ensuring quality assurance, and working on deadline projects while submitting to clients on time.
- Client: Elsevier
Database and Product: SCOPUS, PUBMED, and SCIVAL EXPERTS.
Education
Master of Science - Biotechnology
Reva University
Bengaluru, IN-KASkills
- Trial master file management
- Quality control checks
- Regulatory compliance
- Document version control
Proficiency in Veeva Vault, Intrinsic CTMS, Pharmaseal CTMS, Trial interactive, Phlex global, and EDC
Wingspan
ALCOA Review & TMF Completeness
Debarment Check
Workflow management
TMF Audit
Multitasking efficiency
TMF inspection & Audit readiness
TMF Start-Up & Close out Support
Indexing and QC checks
Gap Analysis
Site Binders
Teamwork orientation
Cross Functional Collaboration
Effective Communication
Process Improvement & SOP Adherence
Team Training & Mentoring
Timeline
TMF Lead
Orcimed Life Sciences
05.2025 - Current
ETMF Specialist
IQVIA, Bangalore
11.2018 - 12.2024
Project Co-Ordinator
Cenveo Publishers
03.2016 - 11.2018
Process associate
Infocon International Ltd
12.2013 - 10.2015
Master of Science - Biotechnology
Reva University