Neelima Lamba
Records Management Analyt
Bengaluru
Summary
Dynamic clinical trials professional with over 10 years of specialized experience in electronic trial master files (eTMF) and clinical document indexing for both DIA and pre-DIA studies. Proven expertise in conducting quality checks and file reviews, ensuring compliance and excellence in eTMF processes. Subject Matter Expert for the Wingspan Mentoring team and QC SWAT team, contributing significantly to system enhancements during UAT testing for WS 2.9 and the Language Translator application. Well-versed in multiple TMF platforms, including ELVIS, Wingspan, Intelligent TMF, and Veeva Vault, consistently delivering high-quality results that drive project success.
Overview
14
14
years of professional experience
5
5
Certifications
3
3
Languages
Work History
TMF Specialist
IQVIA
10.2018 - Current
- Conduct the Comprehensive Quality Trial Master File Review in accordance with eSOPs, Guidance Documents, File Review Overview Form and Project Instruction, when applicable.
- Review documents in line with ALCOA principles.
- Focus on cross checks, co-dependency checks and identification of missing documents.
- Identify metadata and document inaccuracies as Action Items.
- Create Action Items and assign them to users (Document Owners or self).
- Raise valid and clear action items, as per Action Item Response Table or another applicable document.
- Address Action Items assigned to self and close them in accordance with review timelines.
- Review documents within agreed timelines according to guidance documents for respective TMF platform, always complete 100% of cross checks and co-dependency check.
- Support QPM in timely delivery of the comprehensive file review cycle, proactively communicating review finalization.
- Actively communicate findings, trends, file review related questions and escalations to the QPM.
- When assigned, support other TMF related activities.
- Provide support to other TMF Specialists as Buddy or Mentor, when needed.
Sr. Clin Process associate
IQVIA
08.2017 - 10.2018
- Serves as ENF- Indexer, in document filing and processing the documents.
- Provide support & mentor/training to coworkers within RIM.
- Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time.
- Follow processes for setup, maintenance, and support for assigned TMF projects.
- Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate.
- Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues.
- Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor.
- Follow applicable SOP's to ensure completeness & accuracy of TMF.
- Prepare/present TMF related information at internal meetings in a Globally consistent format.
- Provide support & involvement with internal quality or audit process's as relevant.
- Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA's.
- Manage documentation associated with assigned clinical trials.
- Follow records management tasks, policies, and procedures.
- Conduct review documents with compliance to Quintiles or customer file plans and SOPs.
- Collaborates on TMF Quality for assigned sponsor trials.
- Reports TMF health findings at required frequency.
- Alert Project team and TMF Quality PM to any potential TMF Health issues.
- Perform assigned complex administrative tasks to support team members with project execution.
- Assist in updating and maintaining complex data in systems within project timelines and per project plans.
- Interface with departments to support retrieval projects and ensure information needs are met.
- May coordinate transfer, recall, and disposition of records to commercial records storage centers.
- Establish and maintain effective internal and external client communications.
- All documents in ENF Processing Tool to be reviewed, grouped into batches, registered, indexed, QCed according to timelines defined by IQVIA SOP.
- Ensure quality review during the process of Pre QC, Indexing, and Review QC in Elvis as outlined in SOP and guidance documents.
- Actively monitor EEL-Content for batches that are ready for Indexing and/or Review QC for the assigned studies and ensure batches in overdue stage are processed immediately.
- Assist management with the implementation of strategic goals, plans, cost proposals, and resource projections for records management projects.
- May Function as team leader for records management projects.
Clinical process Associate 2
IQVIA
08.2016 - 08.2017
- Complete appropriate role-specific training to perform job duties.
- Undergone Project specific training for Pre-DIA to DIA migration.
- Perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meetings, preparing and distributing status reports, creating and maintaining study documents, etc.)
- Assist in updating and maintaining systems within project timelines and per project plans.
- Actively monitor EEL-Content for batches that were ready for Indexing for the assigned studies.
- Document processing by reviewing the quality of the indexed documents.
- Support SWAT ENF team for clearing backlogs.
Clinical process Associate 1
IQVIA
02.2016 - 08.2016
- Complete appropriate role-specific training to perform job duties.
- Perform assigned administrative tasks to support team members with project execution (examples of such tasks include but not limited to running system reports, maintaining minutes of meetings, preparing and distributing status reports, creating and maintaining study documents, etc.).
- Assist in updating and maintaining systems within project timelines and per project plans.
- Actively monitor EEL-Content for batches that were ready for Indexing for the assigned studies.
- Document processing by reviewing the quality of the indexed documents.
Clinical Process Trainee
IQVIA
08.2015 - 02.2016
- Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures.
- Sort and classify coded material for filing. Create files according to established classification system.
- Ensure that all paper clinical trial records are complete and accurate.
- Maintain log and enter metadata in database to track status and facilitate accurate retrieval of information.
- Maintain a log and indexes to provide status of information and assist in the collection of data for preparation of monthly metric reports.
- File, maintain and process reports, collections, and validations where applicable.
QC -Chemist
Glochem Industries Limited
05.2011 - 03.2012
- Analysis of Drug as a analyst.
- Quality control chemist
- Calibration of drug and equipments.
Education
Masters in Pharmacy - Pharmaceutics
Sri Padmavathi Mahila University
Tirupati, India 04.2001 -
Bachelors in Pharmacy - Pharmacy
Pydah College of Pharmacy
05.2011
Skills
Team collaboration
Certification
ICH GCP E6 (R3) training , 2025
Affiliations
Membership on Pharmacy Council of India, 2012
Training
- Lean Awareness Training 2022.
- Internship for 3 months in FR&D Dr. Reddy’s Lab Ltd., Formulation Unit- IV VSEZ, Duvvada, Visakhapatnam.
- Undergone 3 months Industrial Training in Spectrum Labs, Kukatpally, Hyderabad.
- Undergone one session training on FIRE AND SAFETY MANAGEMENT.
Department Specific Experience
- Department: Data Management
- Category: Clintrial or OC, Experience: N/A
- Department: Records Management
- Category: ELVIS DIA, Experience: 3-5
- Category: ELVIS Pre-DIA, Experience: 3-5
- Category: Intelligent TMF, Experience: 1-3
- Category: IQVIA Wingspan, Experience: 5-10
- Category: VeevaVault, Experience:
- Category: Indexing, Experience: 3-5
- Category: QC, Experience: 3-5
- Category: TMF Specialist (eTMF Files Reviewer), Experience: 5-10
- Category: SME Support, Experience: 1-3
- Category: Records Management Trainer / Mentor, Experience: 5-10
Timeline
TMF Specialist
IQVIA
10.2018 - Current
Sr. Clin Process associate
IQVIA
08.2017 - 10.2018
Clinical process Associate 2
IQVIA
08.2016 - 08.2017
Clinical process Associate 1
IQVIA
02.2016 - 08.2016
Clinical Process Trainee
IQVIA
08.2015 - 02.2016
QC -Chemist
Glochem Industries Limited
05.2011 - 03.2012
Masters in Pharmacy - Pharmaceutics
Sri Padmavathi Mahila University
04.2001 -
Bachelors in Pharmacy - Pharmacy
Pydah College of Pharmacy