SRAVYA GADILI
Hyderabad
Summary
Seasoned Trial Master File Specialist with a proven track record in pharmaceutical documentation and compliance management at Syneos Health, demonstrating expertise in TMF, Veeva Vault, processing study documentation in alignment with SOPs, GCP, and ICH guidelines. Achieved 98% accuracy in quality reviews, enhancing document management efficiency and team performance through effective training and development and Adept at managing Paper Document and Document Control Room (DCR) operations. Skilled in regulatory compliance and fostering collaboration, I excel in high-stakes environments.
Overview
5
5
years of professional experience
Work History
Trial Master File Specialist
OrciMed Life Sciences
Hyderabad
12.2024 - Current
- Managed TMF setup, maintenance, and closure; ensured document security and compliance; performed quality and completeness reviews, supported document control including scanning and indexing
- Hands-on experience and proficiency with Veeva Vault
- Hands-on experience in TMF repository management, quality and completeness reviews
- Hands-on practice in document collection and indexing, document control and DCR management
- Co-ordinate with data management personnel to reconcile key data fields between the safety databases
- Hands on experience in extracting source documentation for different studies
- Hands on experience in managing electronic trial master file (e-TMF) within Veeva Vault, by maintaining accuracy, completeness, quality of the documents
- Hands-on experience in Expected document list (EDL) review, milestone review, Centralized completeness review team CCRT
- Experience in Trial Interactive tool
- Provided technical support and resolved document related issues for team members, enhancing project collaboration and efficiency
- Resolved document related issues through effective liaison with document owners and escalated the issues
- Enhanced Drug control room (DCR) management practices, maintained 100% accurate record keeping system and ensuring timely document delivery
- Implemented compliance tools & trackers, improved quality adherence and productivity standards
- Worked as primary compliance specialist for study, country, site documentation in e-TMF
- Support TMF operations and perform reconciliation tasks like missing documents, deletion request
- Good knowledge of ICH-GCP and TMF guidelines maintaining the high standards of compliance
Trial Master File Specialist III
Syneos Health
Hyderabad
03.2021 - 07.2024
- Company Overview: Home Based
- Processed documentation following SOPs, GCP, and ICH guidelines; managed TMF setup, maintenance, and closure; ensured document security and compliance; performed quality and completeness reviews; and supported document control, including scanning and indexing
- Processed over 200 study documents in alignment with SOPs, GCP, and ICH guidelines, ensuring precise execution of study-specific requirements
- Ensured compliance of 1,000+ documents for archived projects, maintaining high standards
- Successfully set up, maintained, and closed 10 TMF repositories, enhancing document management efficiency
- Scanned and indexed over 500 trial documents using electronic TMF systems, supporting efficient documentation collection
- Conducted quality reviews of 300+ TMF documents, achieving 98% accuracy in compliance
- Completed completeness reviews of TMF content against Expected Document Lists, identifying and resolving missing content for 15+ projects
- Managed Paper Document and Document Control Room (DCR) tasks, including scanning, indexing, and filing 400+ hard-copy documents, maintaining a 100% inspection-ready state
- Implemented compliance tools & trackers, improving quality adherence & 15% productivity standards
- Provided technical support and resolved document-related issues for a team of 10+ members, enhancing project collaboration and efficiency
- Led training sessions for 5+ team members on TMF processes and best practices, improving team competency and performance
- Resolved 50+ document-related issues through effective liaison with document owners and escalation to TMF leads
- Enhanced DCR management practices, maintaining a 100% accurate record-keeping system and ensuring timely document delivery for 30+ requests
- Home Based
ML Data Associate
Amazon Development Centre
Hyderabad
07.2020 - 03.2021
- Collected ground truth data, executed and reported results accurately, maintained quality in repetitive tasks, communicated failures, and met daily targets
- Achieved 98% quality in collecting ground truth data for product development, executing and accurately reporting over 100 results
- Consistently met daily targets, effectively communicated failures, and provided detailed status report while maintaining high productivity and quality standards
Education
Master of Pharmacy - Specialised in Pharmaceutical
G. Pulla Reddy College of Pharmacy
Intermediate - Biology Physics Chemistry
Sri Chaitanya Junior College
Hyderabad, IndiaCertificate Program - Drug Regulatory Affairs
Inorim Life Sciences
Skills
- TMF (Trial Master File)
- Veeva Vault
- Trial Interactive
- Pharmaceutical Documentation
- Compliance Management
- Quality Control
- GCP (Good Clinical Practice)
- SOP (Standard Operating Procedures)
- ICH Guidelines
- Document Control
- Document Scanning and Indexing
- Quality Review
- TMF Repository Management
- Regulatory Compliance
- Clinical Trials Documentation
- Document Management Systems
- Filing
- Electronic Document management System (EDMS)
- Audit Preparation
- Training and Development
Projects
B Pharmacy: Formulation and Evaluation of Mesalamine Matrix Tablets.
M Pharmacy: Formulation and Evaluation of Oral Disintegrating Tablets of Tramadol HCL using Natural Super disintegrating Agents.
Publications
- Formulation and Evaluation of Atenolol Orodispersable Tablets using Natural Superdisintegrants and Multifunctional Excipients, International Journal of Life Sciences and Pharma Research
- Formulation and Evaluation of Zidovudine Transdermal Patch using Permeation Enhancers, Journal of Young Pharmacists, 12, 2(Suppl), 04/01/20
Languages
- English
- Telugu
Timeline
Trial Master File Specialist
OrciMed Life Sciences
12.2024 - Current
Trial Master File Specialist III
Syneos Health
03.2021 - 07.2024
ML Data Associate
Amazon Development Centre
07.2020 - 03.2021
Master of Pharmacy - Specialised in Pharmaceutical
G. Pulla Reddy College of Pharmacy
Intermediate - Biology Physics Chemistry
Sri Chaitanya Junior College
Certificate Program - Drug Regulatory Affairs
Inorim Life Sciences
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