SRIKANTH BIYYALA
Atmakur
Summary
Detail-oriented TMF Specialist 2 with 4 years of clinical research experience, including 2 years in TMF operations. Expertise in Veeva Vault and sponsor-specific eTMF platforms, document processing, metadata management, and quality checks. Conducts TMF health checks, tracks Quality Issues, and supports audit readiness, ensuring compliance and integrity throughout the study lifecycle.
Overview
1
1
Certification
4
4
years of professional experience
Work History
TMF Specialist 2
ICON
Chennai
09.2026 - Current
- Execute and coordinate eTMF operations across sponsor-specific platforms, including Veeva Vault, IComaster, and iSubmit, maintaining document quality and compliance with study requirements and sponsor SOPs.
- Conduct TMF health checks, audit activities, record retrieval, query resolution, and documentation requests to ensure inspection readiness.
- Conducted quality and inspection-readiness reviews to identify and resolve missing, duplicate, incorrect, inconsistent, or poor-quality records with document owners.
- Reviewed Quality Issue (QI) reports, tracked actions, followed up on open issues, and facilitated early closure and escalation of significant quality or compliance concerns.
- Monitored document quality, productivity benchmarks, submission timelines, and project metrics; prepared ad hoc reports to support calibration and operational oversight.
- Perform document processing, upload, classification/indexing, metadata checks, reconciliation, and coherence verification; identify discrepancies affecting accuracy, filing, and completeness.
- Provide day-to-day peer support and train/onboard new hires on sponsor-specific systems, document quality expectations, and TMF best practices.
- Apply ICH-GCP, DIA TMF Reference Model principles, data-integrity practices, and sponsor SOP requirements to day-to-day TMF activities.
- Assigned documents daily to team members based on their skill sets and availability.
TMF Specialist 1
ICON
Chennai
06.2024 - 08.2026
- Performed TMF document QC, processing, indexing, reconciliation, and quality checks across clinical studies.
- Conducted completeness and inspection-readiness reviews, identifying and addressing missing, duplicate, incorrectly indexed, and poor-quality documentation.
- Reviewed document metadata, properties, and filing quality in sponsor-specific eTMF platforms and raised discrepancies for correction.
- Conducted cross-check and coherence verification to confirm related records were complete and consistent.
- Managed end-to-end processing and quality review of critical pharmacovigilance documentation, including Expedited Safety Reports, Periodic Line Listings, and regulatory submissions in full compliance with GVP and ICH guidelines."
- Generated and reviewed QI reports, collaborated with document owners to resolve issues promptly.
- Facilitated periodic TMF health checks, ensuring audit readiness and effective query resolution while monitoring metrics and productivity.
Clinical Research Coordinator
Koncord Clinical Research Services
Remote
07.2023 - 06.2024
- Supported study initiation, investigator meetings, trial execution, recruitment, informed consent, CRFs, source documentation, and study timelines.
- Coordinated with cross-functional teams, trained new team members on protocols and procedures, and monitored/reporting adverse events in accordance with study requirements.
- Applied quality-control measures to reduce data-entry errors and proactively resolved study issues and risks.
- Screened patient records, databases, and physician referrals to identify prospective study candidates.
Associate Clinical Data Coordinator
IQVIA
Bangalore
09.2022 - 05.2023
- Conducted clinical data review and cleaning, including vendor and SAE reconciliation, ensuring data integrity for accurate study outcomes.
- Reviewed SAS listings and managed queries to resolve data discrepancies efficiently.
- Performed User Acceptance Testing (UAT) to verify system functionality against project requirements.
- Reviewed data-management study documents per DMSF/PRCF guidelines, facilitating TMF review activities for compliance.
- Facilitated data clarifications and coordinated clinical data-management lifecycle deliverables, meeting established timelines and quality standards.
Education
Bachelor of Pharmacy (B.Pharm) -
Sree Vidyanikethan College of Pharmacy
TirupatiSkills
- ETMF Document Processing, Classification and Indexing
- TMF reconciliation
- Quality issue resolution
- Metadata validation
- TMF health checks
- Inspection & Audit Readiness
- Data integrity practices
- GCP compliance
- TMF model awareness
- ETMF systems expertise
- Clinical systems proficiency
- Complex record review
- Operational reporting skills
- Process improvement support
- Discrepancy identification
- Operational metrics
- Inspection readiness
- Audit support
- Workflow Standardization and Continuous Improvement
- Microsoft Excel & MS Office
- Stakeholder coordination
- Stakeholder communication
- Peer training
- Issue resolution
- Multiple-study/task management
- Audit support
Certification
Certification in Advanced Training in Clinical Research and Data Management; ICH-GCP Certification
Timeline
TMF Specialist 2
ICON
09.2026 - Current
TMF Specialist 1
ICON
06.2024 - 08.2026
Clinical Research Coordinator
Koncord Clinical Research Services
07.2023 - 06.2024
Associate Clinical Data Coordinator
IQVIA
09.2022 - 05.2023
Bachelor of Pharmacy (B.Pharm) -
Sree Vidyanikethan College of Pharmacy