Prithvishree BR
Bengaluru
Summary
Clinical operations professional experienced in FDA compliance, clinical research, and trials. Skilled in leading teams in high-stakes oncology and COVID-19 trials to ensure data integrity and quality assurance. Expertise in clinical data management and strong interpersonal skills. Committed to contributing to medical advancements and enhancing patient care.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Associate Manager- Source Configuration
Reify health (One study team)
Remote
03.2024 - 09.2024
- Developed and implemented strategies to ensure cost-efficient operations.
- Facilitated the development of staff by providing training, coaching, and feedback.
- Managed daily workflow of team members to meet organizational goals.
- Utilize beginner-level Python and JSON for efficient CRF and EDC development
Senior Clinical Data Manager
George Clinical
Bengaluru
09.2019 - 02.2024
- Developed and implemented data management plans for clinical trials in accordance with regulatory guidelines.
- Monitored the accuracy of data collected from multiple sources to ensure that quality standards were met.
- Coordinated activities between Clinical Data Management team members, biostatisticians, and other departments as needed.
- Led strategy development, critical thinking initiatives, and problem resolution while coordinating internal teams.
- Expertise in COVID-19 trials - project lead for vaccine and drug trials, and proud to mention that the approval was obtained and successfully used as emergency treatment for COVID infection.
- Apart from these, I have worked extensively on nephrology, respiratory phase III, and IV studies.
Senior Technical Designer
Techno Soft (Based at Client's office-IQVIA,Bangalore)
Bengaluru
09.2018 - 09.2019
- Rave build and migration (7 oncology trials).
- Wrote SAS specifications for automated edit checks.
- eCRF's testing and Validation
- Team training.
- Developed and implemented technical specifications.
Senior Clinical Database Programmer
Quartesian (Now called as Veranex)
Bengaluru
06.2017 - 07.2018
- Oversaw performance and development of 5-person team.
- Conducted training sessions for over 10 team members on UAT and validation processes.
- Gained experience with Medidata Rave, Medrio, and ClinCapture clinical databases.
- Developed multiple clinical research frameworks and validation protocols
- Built comprehensive Working Instructions document for UAT of eCRFs and edit checks
- Recognized for significant contributions with rapid advancement to Senior CDP
Clinical Data Associate
Novotech Pvt Ltd
Bengaluru
03.2016 - 03.2017
- Reviewed and monitored clinical data to ensure accuracy and validity of results.
- Developed and maintained databases for the collection, storage, retrieval, analysis and reporting of clinical trial information.
- Performed quality control checks on all clinical data entered into the database.
- Testing and validation of eCRFs and edit checks.
- Data Management Plan preparation, Lab management documentation.
- Edit check specification preparation, Protocol review and eCRF review, discrepancy management, etc.
- Safety database implementation: ARGUS (Testing).
- Managed over 20 database locks related to CKD and oncology studies.
- Engaged with Medidata Rave and Viedoc platforms
Clinical Research Associate
Novotech Pvt Ltd
Bengaluru
10.2014 - 02.2016
- Performed clinical research activities including protocol development, subject recruitment and data collection.
- Reviewed and monitored clinical trial sites to ensure compliance with Good Clinical Practices guidelines.
- Developed and managed budgets for clinical trials according to study protocols.
- Feasibility check, Organizing IMs.
- Monitoring of phase II, III, and IV trials (Oncology and Diabetes, Nephrology).
- Reporting and documenting of SAEs, project coordination between sites and sponsor (global), drug accountability at sites, site training, site initiation, site close out visits, etc.
- TMF maintenance and filing.
- CTMS super admin.
- CTMS super admin.
Clinical Research Coordinator
Lotus Labs Pvt Ltd
Bengaluru
07.2012 - 10.2014
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
- Developed and maintained accurate and timely study databases.
- BA/BE trials, Phase I/II included therapeutic areas like Respiratory, Psychiatry, Dermatology, Nephrology, and FMCG studies.
Clinical Research Coordinator
Kidwai Institute of Oncology
Bengaluru
09.2011 - 05.2012
- Patient visit planning, drug accountability, source documentation, and EDC entry.
- Attending site initiation visits, site monitoring visits, and site closeout visits.
- Site initiation visits, site monitoring visits, and site closeout visits.
- Phase III and Phase IV oncology studies, SAE filing, and follow-up.
Trainee Analyst
MS Ramaiha Drug testing Laboratories
Bengaluru
03.2011 - 05.2011
- Water and Soil Analysis
- Pre-clinical trial activities
- Participated in obtaining ISO certification for the lab.
Education
Advanced PG Diploma - Clinical Research
Medvarsity, Appollo Institutions
Distance Study03-2015
Master of Science - Biotechnology
MLACW
Bengaluru10-2010
Bachelor of Science - Chemistry, Botany And Biotechnology
SJRCW, Rajajinagar
Bengaluru05-2008
Skills
- Certified IBM Clinical Database Designer
- Base SAS
- Python (beginner level)
- Data Analytics with Excel (Simplilearn)
- Data Visualization with Power BI (Great Learning)
Affiliations
- Passionate Carnatic Classical Vocalist
Languages
Kannada
First Language
English
Upper Intermediate (B2)
B2
Certification
- IBM Clinical Development Database - Designer (2019)
Timeline
Associate Manager- Source Configuration
Reify health (One study team)
03.2024 - 09.2024
Senior Clinical Data Manager
George Clinical
09.2019 - 02.2024
Senior Technical Designer
Techno Soft (Based at Client's office-IQVIA,Bangalore)
09.2018 - 09.2019
Senior Clinical Database Programmer
Quartesian (Now called as Veranex)
06.2017 - 07.2018
Clinical Data Associate
Novotech Pvt Ltd
03.2016 - 03.2017
Clinical Research Associate
Novotech Pvt Ltd
10.2014 - 02.2016
Clinical Research Coordinator
Lotus Labs Pvt Ltd
07.2012 - 10.2014
Clinical Research Coordinator
Kidwai Institute of Oncology
09.2011 - 05.2012
Trainee Analyst
MS Ramaiha Drug testing Laboratories
03.2011 - 05.2011
Advanced PG Diploma - Clinical Research
Medvarsity, Appollo Institutions
Master of Science - Biotechnology
MLACW
Bachelor of Science - Chemistry, Botany And Biotechnology
SJRCW, Rajajinagar
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