K USHA SRI
Clinical Data Specialist
Bengaluru
Summary
- Around 4+years of Rich experience in Clinical Data Management system
- Good knowledge about Clinical Data Management Systems Proficient in validating data in different phases of study in clinical trials.
- Have experience and operating in medidata RAVE in CDMS • Have knowledge Performed Study-conduct and study- close out activity.
- Therapeutic Areas: Oncology, COVID-19 , Hematology and Allergy/Immunology.
Overview
5
5
years of professional experience
4
4
Languages
Work History
Clinical Data Specialist
IQVIA
04.2022 - Current
- Perform data management activities with focus on quality and study timelines as per study protocol.
- Serve as Data Operations Coordinator (DOC) for one or two global studies with fewer than 10 Operations staff or serve as leadership role to specific DM tasks.
- Worked on various study setup, conduct and close out activities, assisted in UAT activities in setup phase.
- Performed Third party data reconciliation and SAE reconciliation.
- Perform External data reconciliation for IVRS, LAB, ECG, Patient dairies and take appropriate action for data mismatch and missing data.
- Perform early and final database QC activities.
- Perform Data Quality listing review and take appropriate action accordingly.
- Perform listings specification review, CPT speciation review and take appropriate action accordingly.
- Attend Project Plan meeting, Conducting DM meetings with ST and provide inputs wherever required.
- Perform locking and freezing activities
- Worked on study metrics creation.
- Mentoring new joiners and providing training on organization specific Data management workflow.
- Involved in innovation such as creating end to end DM activities document with reference of organization specific Data management SOPs.
- Enhanced data accuracy by implementing stringent quality control measures and processes.
- Worked on post production changes like drafting Post production change request and its implementation.
Executive (Clinical Data Management)
SANOFI
07.2019 - 01.2022
- Reviewed manual Listings and auto discrepancies according to the listing
- To Perform Lab reconciliation Lab (Vendor)reconciliation and SAE reconciliation
- Reviewing of Patient summary, update database, generate queries and query resolving
- To perform manual review listing raising a query for inconsistent data
- Review and resolve data discrepancies identified by system or through manual checks as identified in data review plan
- Proficient in validating data in different phases of study by creating Edit Checks, Query logics for efficient Discrepancy Management of Data in EDC studies and performing User Acceptance Testing (UAT)
- Worked on different phases of study & Therapeutic area of Cardiology and Endocrinology (Diabetes)
- Performed Quality Check (QC) of the data by manual review
- Worked extensively on study closing activities including Data Review, Data freezing and Study Lock.
Education
B-tech Biotechnology -
Kalasalingam Academy of Research And Education
Intermediate -
Sri Chaitanya Kalashala Tirupati
SSLC -
Kendriya Vidyalaya, Tirupati
Skills
Excellent Communication
Task Prioritization
Adaptive Learning Capacity
Quality Control
Self Motivation
Accomplishments
- Merit scholarship from college.
- IQAC award for best mini project "Insilico analysis of genome and proteome of zika virus".
- Second position in community service project "Production of vermiwash as a fertilizer".
- Second position in department level paper presentation "Nanosponges drug delivery".
- Completed NPTEL online certificate course entitled "Waste to energy conversation".
Activities
- Presented a paper on "Nanosponges drug delivery" in KARE.
- Presented a poster on "Insilico analysis of zika virus genome" in NATIONAL CONFERENCE KARE.
- Participated in WOMEN EMPOWERMENT Workshop in KARE.
- Participated in various clubs in KARE.
- A part of NSS team organised in Thevarkulam for seven days.
Field Of Interest
- Clinical studies
- Drug design
- Bioinformatics
- Microbiology
Publications
Dr. Vanavil Balakrishnan, Dr. Selvaraj Kunjiappan, Miss Ananandhalakshmi, Miss Usha Sri K, Bioactive and Thermostable Sulphated Polysaccharide from Sargassum swartzii with drug delivery applications (2019), International Journal of Biological Macromolecules.
Projects
Green synthesis of nanoparticles, Spectral characterization of synthesized nano particles, anti-bacterial activity assay, Disc diffusion methods., 20 days T cell prediction of zika virus, Predicted the T cell epitope using SYFPEITHI for membrane glycoprotein, capsid protein, envelop protein, anchored capsid protein., 4 months In silico analysis of genome and proteome of zika virus, Analyzed genome and proteome of zika virus by using promoter2.0 tool, ORF regions, NEB cutter, PROTPARAM and peptide cutter., 4 months Production of vermiwash as fertilizer, Vermiwash is biofertilizer, aimed at exploring the growth promoting effects of vermiwash., 1 year
Disclaimer
I hereby declare that the information stated above are true and correct to the best of my knowledge and belief. I take responsibility of any mistakes in data if occur in future.
Timeline
Clinical Data Specialist
IQVIA
04.2022 - Current
Executive (Clinical Data Management)
SANOFI
07.2019 - 01.2022
B-tech Biotechnology -
Kalasalingam Academy of Research And Education
Intermediate -
Sri Chaitanya Kalashala Tirupati
SSLC -
Kendriya Vidyalaya, Tirupati