NARESH MAILAPILLI
Manager, Clinical Data Management
Bengaluru,Karnataka
Summary
Service-oriented Manager with 11 years of relevant experience in Clinical coding and supporting various CDM requirements. Strong leader and problem-solver dedicated to streamlining operations. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Uses independent decision-making skills and sound judgment to positively impact company success. Proven history of efficiency and reliability.
Overview
11
11
years of professional experience
6
6
years of post-secondary education
Work History
Manager, Clinical Data Management
AGATI Clinical Informatics
Bengaluru, Karnataka
08.2020 - Current
- Supervising staff of 11 personnel by implementing company policies, work rules and disciplinary action
- Provide coding and CDM trainings to coach and develop team members
- Coding lead and project manager for clinical data management studies
- SME for coding activities on iMedidata coder and PACE tools
Support study set-up for new CDM projects working in Viedoc and Medidata Rave databases - Strong technical knowledge and hands-on experience on coder tool implementation
- Present strong coding capabilities for new project assignments
- Support eCRF design, database build, edit checks review, UAT testing, coder implementation activities for assigned studies
- Received study design and build essentials, coder accreditation trainings on Medidata Rave and Coder
- Technical support on End-point adjudication case processing, clinical review (study drug unblinding, subject identifiers/PHI redactions), Narrative writing
- Attended team building and leadership trainings at Pegasus academy
- Conduct interviews and partners in selection process, job description preparation for career progression roles
- Manage resources in FSP and Non-FSP project assignments
- Provide technical Support and guidance to direct reports as needed
- Develop staff who demonstrate expertise in technical and functional assignments
- Manage audit readiness, quality and compliance to ensure deliverables are accurate
- Leads and directs team members in achieving developmental goals
Clinical Data Coder II
PAREXEL International India Pvt.Ltd
Hyderabad, Telangana
08.2015 - 04.2020
- Primary coder handled end-to-end (Set-up, conduct and close-out) clinical coding activities on assigned projects (38 studies)
- SME for Medidata coder implementation and UAT review
- Performed WHODrug B3 format implementation on OC TMS, Medidata Coder
- Resolved dictionary value truncations and priority overlapping issues on Medidata coder tool
- Prepared iMedidata coder training materials, provided presentations on (Coding review, Medidata Coder set-up challenges and Audit readiness)
- Oversaw daily operations to ensure high levels of productivity and quality
- Participated in internal and external audits of all coding projects
- Support fellow team members in coding UAT and UTR review
Associate Clinical Data Coordinator
IQVIA, Formerly Quintiles
Bengaluru, Karnataka
01.2014 - 08.2015
- Lead Coder handled with end-to-end (Set-up, conduct and close-out) clinical coding activities on assigned 5 Medidata coder and 28 OC RDC – TMS studies
- Performed coding and review using global and study specific coding conventions
- Performed SAE reconciliation alongside coding for 6 months
- Maintain all study documentation in respective project folders for audit readiness
- Reconcile monthly productivity and QC trackers to create coding metrics and to assess coding quality
Junior Data Analyst
Cognizant Technology Solutions, CTS
Mumbai, Maharashtra
02.2012 - 01.2014
- Clinical Coding activities (study conduct to database lock) on OC RDC – TMS, Inform central coding
- Clinical Coding data reviewed in OC – TMS using Glossary and J-review reports
- Discrepancy management on OC-RDC database
- Global Pharmacovigilance coding on Clintrial Classify
Education
Master of Pharmacy - Pharmaceutical Management And Regulatory Affairs
Siddhartha Institute of Pharmaceutical Sciences
Acharya Nagarjuna University, Guntur 11.2017 - 12.2019
Bachelor of Pharmacy - Pharmaceutical Sciences
A M Reddy Memorial College of Pharmacy
Acharya Nagarjuna University, Guntur 10.2007 - 04.2011
Skills
Clinical Coding (MedDRA/WHODrug)
undefinedWork Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Manager, Clinical Data Management
AGATI Clinical Informatics
08.2020 - Current
Master of Pharmacy - Pharmaceutical Management And Regulatory Affairs
Siddhartha Institute of Pharmaceutical Sciences
11.2017 - 12.2019
Clinical Data Coder II
PAREXEL International India Pvt.Ltd
08.2015 - 04.2020
Associate Clinical Data Coordinator
IQVIA, Formerly Quintiles
01.2014 - 08.2015
Junior Data Analyst
Cognizant Technology Solutions, CTS
02.2012 - 01.2014
Bachelor of Pharmacy - Pharmaceutical Sciences
A M Reddy Memorial College of Pharmacy
10.2007 - 04.2011
Custom
- Medidata RAVE & Coder
- VIEDOC/Protocol First (FLATIRON) & PACE iCODER
- INFORM & Central Coding
- OCRDC & TMS
- Clintrial classify
Custom
- LinkedIn learnings and TED talks
- Cooking and Travelling
- Playing volleyball, Shuttle badminton and caroms
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