Prasanna Lakshmi
Hyderabad
Summary
Aspiring to excel in the dynamic field of Clinical Research and Clinical Data Management by leveraging my knowledge, skills, and dedication. Committed to contributing to the organization's growth through hard work, precision, and a results-driven approach.
Overview
7
7
years of professional experience
Work History
Clinical Data Manager
Sylphid Analytics Pvt Ltd
05.2025 - 12.2025
- Develop long term/short term execution plans for Data Management function in line with CD and program strategy.
- Cascade plan to team members, allocate work and resource for Project. Evaluate project plans in periodic functional reviews.
- Ensure timely achievement of key deliverables in the desired quality. Resolve issues and escalation for smooth execution.
- Expertise in the below activities: Clinical Data Management: Startup Phase.
- Provide Protocol Training to the team, protocol reviews.
- Preparation of Data Management Plan, Data Transfer Specification Document, Database Specification Document, Edit Checks Document as per client requirement.
- Database Designing in EDC and Performed User Acceptance Testing.
- Involved in Test Case Creation, Edit checks Validation and Email alerts validation for both Build and Migration studies.
- Documented ECRF completion guidelines and all required other process related documents in TMF.
- Actively participated in Golive process.
- Actively interacted and coordinated with different teams like Programming, TD, Medical Monitor, clinical operations and CRA’s, Investigators(PI’s), and, Sponsor.
- Generated reports like Defect logs, Quality report and DVS, Post execution report and EDC build problem report, Data Base extract, Queries report.
- Conduct phase: Performed data entry in EDC.
- Expertise in Listings review and other data reviews like MM queries, etc.
- Query Management: Open queries, closed queries, responded queries, reopened queries.
- Performed Lab reconciliation, SAE reconciliation, PK Reconciliation, ICL reconciliation etc.
- Close out Phase: DB Checklist preparation.
- Performed Data base freezing and hard lock.
- Archival of study.
- FSP to Dr Reddy’s Laboratories Limited
Associate Clinical Data Manager
Ora Clinical Research India Pvt. Ltd.
02.2024 - 05.2025
Clinical Database Validation Specialist
IQVIA RDS Pvt. Ltd.
01.2021 - 01.2024
Clinical Data Analyst
Inductive Quotient Analytics Pvt. Ltd.
07.2018 - 12.2020
Education
B.Sc. Nursing -
Bollineni college of nursing
Nellore01.2017
Intermediate -
Sri Lakshmi Vocational Junior College
01.2013
SSC -
Prathyusha English Medium High School
01.2011
Skills
- ICH-GCP adherence
- Data management planning expertise
- Regulatory compliance expertise
- ECRF compliance guidelines
- BA/BE study planning
- Database specification knowledge
- Clinical trial phases management
- Lab reconciliation and SAE documentation
- CRF and ICF management strategies
- Study build and form design expertise
- SOP formulation skills
- User acceptance testing (UAT) proficiency
- Clinical data management practices
- Test case documentation and validation
- Database validation processes(Listings) skills
- Electronic data capture techniques
- HTML basics knowledge
- Report generation skills
- Sponsor communication and query handling skills
- Ethics committee submission processes
- Expertise in Veeva TMF
Languages
- Telugu
- English
- Hindi
Personal Information
- Date of Birth: 10/04/1996
- Gender: Female
- Nationality: Indian
- Marital Status: Married
Hobbies and Interests
- Playing Shuttle
- Watching TV
- Dancing
- Reading Books
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge and belief.
Father's Name
Ramachandra Raju
Tools Or Databases
- Oracle C1 one
- Medidata Rave
- IMedNet
- Open Clinica
- MS Office
- ALM
- VeeVa
Timeline
Clinical Data Manager
Sylphid Analytics Pvt Ltd
05.2025 - 12.2025
Associate Clinical Data Manager
Ora Clinical Research India Pvt. Ltd.
02.2024 - 05.2025
Clinical Database Validation Specialist
IQVIA RDS Pvt. Ltd.
01.2021 - 01.2024
Clinical Data Analyst
Inductive Quotient Analytics Pvt. Ltd.
07.2018 - 12.2020
B.Sc. Nursing -
Bollineni college of nursing
Intermediate -
Sri Lakshmi Vocational Junior College
SSC -
Prathyusha English Medium High School