Dr. Richa Shukla
Bangalore
Summary
Leadership experience in the clinical coding domain with a medical educational background. Expertise of fourteen plus years of clinical and coding including contributions to development/ validation of coding tools, bringing automation via AI/ML in coding process, project management, team building, training, coaching, mentoring and continuous learning.
Proficiency in the principles of clinical coding, use of MedDRA and WHODRUG dictionaries with knowledge of tools such as Veeva, ICDS, Oracle TMS, OC-RDC, Inform, Medidata Rave, Ecos, Medrio, Eclipse, Veeva Vault, Outcome, QCode, etc. Organizer and presenter at several MedDRA-UMC User Group meetings, SCDM and other forums.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Manager, Clinical Coding and Dictionary
GSK Pharmaceuticals
Bangalore
06.2021 - Current
- Set-up of a new coding team, knowledge transfer, process simplification and improvement.
- Managing and oversight of coding team's coding related decisions, workload, consultation, internal and external communication with all the stakeholders.
- Process simplification and automation. Implemented AI/ML in the coding process.
- Adoption of new coding tool, and its successful implementation within team and associated vendors.
- Collaboration with Veeva team for enhancements.
- Coaching, training and mentoring internal and vendor coding teams.
- Liaising with cross-functional teams.
- Representation and participation in global forums for continuous learning and improvement.
Sr. Clinical Coder
Covance
Bangalore
06.2018 - 06.2021
- Data Management Processes, independently serving as lead coder, including but not limited to performing coding and coding review independently using standard coding dictionaries MedDRA and WHODrug.
- ATC coding following ATC guidelines.
- Coding dictionary up-version and validation.
- Worked simultaneously for multiple clinical trials in various therapeutic areas, e.g. Oncology, Hematology, Ophthalmology, Cardiac, Metabolic, Neurology, Genitourinary, Gastroenterology, vaccines, devices, etc.
- Developed Protocol specific coding guidelines, validation of coding set up, start-up, production and close out activities, SAE reconciliation, review of coded data, coding reports.
- Query management and data clarification.
- Creation and QC of Synonym lists.
- Managing end to end communication with study team, sites, and sponsor.
- Managing project timelines and quality issues.
- Organizing training and mentoring teammates and study teams on a regular basis.
- Mentoring new joiners on Job Training and conducting training for Medical Coding batches, coding guidelines (standard as well as client specific) and coding database.
- Organizing team building activities, innovation, and implementation of new ideas for process and personal improvement.
- Contributing towards improvement in the process, including providing quality and compliance metrics, productivity metrics to the management.
- Played an important role as a POC for major clients.
Sr. Clinical Data Coordinator
IQVIA
Bangalore
02.2015 - 05.2018
- Data Management Processes, independently serving as lead coder, including but not limited to performing coding and coding review independently, using standard coding dictionaries MedDRA, WHODRUG, CTCAE.
- Served as POC for major clients, managing end to end communication.
- Developed a single Unique term report for all active studies for a client portfolio and received a client appreciation award as well as Iqvia outstanding award.
- Mentoring and coaching for team members.
Medical Coder
Cognizant Technology Solutions
Mumbai
11.2013 - 01.2015
- Coding and coding review independently using standard coding dictionaries MedDRA and WHODRUG.
- Query management and data clarification.
- Creation and QC of Synonym lists.
- Organizing team building activities, innovation, and implementation of new ideas for process and personal improvement.
- Contributing towards improvement in the process, including providing quality and compliance metrics, productivity metrics to the management.
Medical Coder
Max Neeman Medical International
New Delhi
05.2012 - 11.2013
IqviaWHODrugQCodeMedrio
- Clinical Drug Development/ Research Process
- Good Clinical Practices
- Performing coding and coding review independently using standard coding dictioWHODrugMedDRA and WHODrug.
- ATC coding following ATC guidelines.
- Query management and data clarification.
Education
Certificate in Leadership Skills -
Indian Institute of Management
Ahmedabad02-2024
PG Diploma in Medical Law And Ethics -
National Law School of India University
Bangalore, Karnataka10-2022
PG Diploma in Clinical Research -
Apheta Institute of Clinical Research School
New Delhi, India06-2012
Bachelor of Dental Surgery -
Maharshi Dayanand University
Rohtak, Haryana10-2010
Skills
- Leadership
- AI/ML
- Team Management
- Project Management
- Matrix Management
- Agile
- Communication
- Presentation
- Adaptability
- Interpersonal skills
- Continuous Learner
- Problem-solving
Certification
- Certified Clinical Data Manager (CCDM)
- Machine learning (University of London)
- Project Management Simplified
- Basics of Power BI
Accomplishments
- Ahead Together Award- CEO, GSK (Feb 2023)
- CDM Star- Covance India Pharmaceuticals (Dec 2019)
- Client Award- Covance India Pharmaceuticals (Mar 2019)
- Client Excellence- Covance India Pharmaceuticals (Oct 2018)
- Client Award - Iqvia (Mar 2018)
- Outstanding achievement award - Iqvia (Jul 2017)
- Neeman Star - Max Neeman (Feb 2013)
Timeline
Manager, Clinical Coding and Dictionary
GSK Pharmaceuticals
06.2021 - Current
Sr. Clinical Coder
Covance
06.2018 - 06.2021
Sr. Clinical Data Coordinator
IQVIA
02.2015 - 05.2018
Medical Coder
Cognizant Technology Solutions
11.2013 - 01.2015
Medical Coder
Max Neeman Medical International
05.2012 - 11.2013
Certificate in Leadership Skills -
Indian Institute of Management
PG Diploma in Medical Law And Ethics -
National Law School of India University
PG Diploma in Clinical Research -
Apheta Institute of Clinical Research School
Bachelor of Dental Surgery -
Maharshi Dayanand University
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