Summary
Overview
Work History
Education
Skills
Affiliations
Additional Skills
Other Relevant Information
Timeline
Generic

Rajiv Kumar Rai

Bangalore

Summary

Accomplished Associate Director of Medical Coding at Fortrea, with a proven track record in enhancing data management processes and implementing global SOPs, ensuring high-quality service delivery. Skilled in MS Word and Excel, and adept at fostering strategic client relationships. Demonstrates leadership by effectively managing and training teams, contributing to a significant increase in department efficiency and client satisfaction.

Overview

21
21
years of professional experience

Work History

Associate Director, Medical Coding

Fortrea
07.2023 - Current
  • Company Overview: Formerly Labcorp Drug Development India Private Limited
  • Ensure that the work carried out in the Data Management department is in strict accordance with relevant protocols, Standard Operating Procedures and Good Clinical Practice and that the quality of all services meets or exceeds customer requirements
  • Collaborate with peers to develop and/or implement global harmonized SOPs and specific quality processes and procedures for Data Management activities
  • Responsible for managing the Data Management department including managing performance and career development via the PMD process, regular catch ups and status meetings and ensuring that all group members are aware of objectives and job responsibilities
  • Ensure attention is also paid to interpersonal skills and achievement of competency standards
  • Review any individual issues with managers and staff proactively and in a timely fashion, work with the supervisors to resolve all issues in a supportive manner, creating and maintaining performance plans, as appropriate
  • Provide constructive feedback as appropriate
  • Collaborate with peers to establish global Data Management competency models and assist with the development of training programs and ensure staff achievement of position competencies
  • Provide leadership guidance and support to Data Managers to ensure that studies are delivered according to Sponsor requirements on time, to high quality and within budget
  • Manage all project team members effectively providing training, acting as source of advice and performing oversight as appropriate
  • Overall responsibility for departmental recruitment and hiring decisions
  • Determine required staffing levels to meet short term and long-term department needs, liaising with senior management as appropriate
  • Ensure that all new hires are assigned objectives and receive applicable training
  • Develop and approve departmental strategies and objectives that align with company-wide goals and targets
  • Review and approve department metrics for input into financial costing models
  • Ensure that these are kept up to date and that Business Development is aware of any updates
  • Provide financial oversight to drive profitability and ensure departmental financial targets and business requirements including expected margins are met
  • Establish global Data Management processes and implement process improvements to increase efficiency and to ensure standards are applied consistently
  • Provide input into new tools and technologies and make informed decisions regarding which new systems are to be implemented, liaising with technical leaders as appropriate
  • Actively participate in business development activities including Bid Defenses, Request for Proposals (RFPs) and Request for Information (RFIs)
  • Work closely with our Business Development representatives in maximizing new or existing business opportunities
  • Act as an advisor to other departments and functions regarding data management activities as appropriate
  • Establish and maintain strategic client relationships, managing issues and escalations efficiently and effectively, and implement appropriate action plans to address client feedback (i.e., customer survey results) as necessary
  • Manage and participate in client, internal or agency audits and inspections
  • May include leading or participating in root cause analyses and tracking and monitoring corrective and preventative actions (CAPA)
  • Implement and monitor client or partnership level Key Performance Indicator (KPI) results as an objective measure of performance
  • Formerly Labcorp Drug Development India Private Limited

Associate Director, Medical Coding

Labcorp Drug Development India Private Limited
10.2020 - 06.2023
  • Acting as account lead, or internal or external point of contact on standalone coding studies or accounts
  • Provide Leadership, project specific trainings, stakeholder management, external sponsor support & project management for required coding tasks supporting clinical trial activities
  • Manage the customer relationship for project team including active participation in coding related customer negotiation on timelines, and budgetary and other issues
  • Act as subject matter expert, providing technical support and expert advice to internal & external stake holders
  • Manage single and multiple service projects, ensuring quality deliverables on time, within budget and to the customer's satisfaction
  • Provide expert skills as a part of a clinical data management team to provide quality data that meet customer needs
  • Work in collaboration with product development/ product management to enhance home grown automation tools
  • Working with data management team and data management customers to assure that coding is performed according to clinical coding guidelines, customer specific guidelines and internal SOPs
  • Manage resource capacity for team
  • Billing & Forecasting pertaining to coding
  • Collaborate with customers and develop solutions and action plan for issues, escalations and road blocks
  • Identify and implement processes and quality improvement initiatives in the DM and coding function
  • Provide review and expert opinion in developing, revising, and maintaining standard core operating procedures and work instructions
  • Support Quality Management efforts through the production and maintenance of technical supporting documentation and ensure that documentation is compliant with corporate quality standards, SOPs/Work Instructions/Guidelines, appropriate regulations and validation requirements
  • Maintains resource staff by recruiting, selecting, orienting, and training employees

Senior Manager, Data Management (Coding)

Covance India Pharmaceutical Services Private Ltd
10.2016 - 09.2020
  • I am responsible for managing and supporting all regionally based operations of projects requiring medical coding services, responsible for selection, hiring, training, development and performance management for a team of staff within clinical data management (medical coding)
  • Assign tasks and responsibilities within clinical data management to team members, in a manner-that optimizes team capability, delivers timely and accurate results, and supports the needs of the business
  • Actively monitor resource requirements within team with feedback to the line management
  • Participate in business development presentation and bid development

Manager, Data Management (Medical Coding)

Chiltern India Pvt. Ltd.
Bangalore
09.2014 - 09.2016
  • Perform coding using web-enabled dictionary and coding management system (eg
  • OC TMS and ds Navigator) or other system as required
  • Perform coding in accordance with study specific coding conventions as outlined in the Data Management Plan (DMP) for assigned projects
  • Perform coding using MedDRA and WHO Drug or other Sponsor specified dictionaries
  • Participate in system upgrades, including User Acceptance Testing (UAT to maintain a validated coding environment
  • Provide support, training, mentoring, feedback and performance/competency input for all dictionary specialists
  • Comprehensive understanding of all tasks and responsibilities associated with Clinical Data Management and coding processes and procedures
  • Assist with resolving coding issues raised by the Sponsor or project team member via consultation with other departments such as Pharmacovigilance

Manager, Dictionary Management and Medical Coding

Theorem Clinical Research India Pvt. Ltd.
08.2014 - 08.2015
  • Apply breadth and depth of Coding skills to develop tools and process improvements that benefit the Coding team
  • Perform coding using web-enabled dictionary and coding management system (eg
  • OC TMS and ds Navigator) or other system as required
  • Perform coding in accordance with study specific coding conventions as outlined in the Data Management Plan (DMP) for assigned projects
  • Perform coding using MedDRA and WHO Drug or other Sponsor specified dictionaries
  • Participate in system upgrades, including User Acceptance Testing (UAT to maintain a validated coding environment
  • Provide support, training, mentoring, feedback and performance/competency input for all dictionary specialists
  • Comprehensive understanding of all tasks and responsibilities associated with Clinical Data Management and coding processes and procedures

Business Advisor Specialist

Accenture Services India Pvt. Ltd.
01.2012 - 07.2014
  • Serve as primary point of contact for customer on data management deliverables; manage multiple large studies or program of studies
  • Provide leadership and senior support to OADM on project management activities
  • Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
  • Serve as the escalation point for unresolved data issues; independently work with client data managers, vendors and internal team members for resolution
  • Review and develop solutions, action plans, contingency plans with operations for consideration/management as appropriate
  • Assessing and managing project realization and project utilization
  • Define resource requirements and work with supervisor to prioritize resource assignments across projects
  • Assess and document competency of staff to satisfy position responsibilities
  • Regularly set goals and evaluates and documents performance
  • Approving both the MedDRA and WHODRUG terms coded by the team members
  • To manage a team of 3 persons and providing their performance feedback
  • Acting as a business advisor to the client

Team Lead (Medical coding Specialist)

Accenture Services India Pvt. Ltd.
07.2009 - 12.2011
  • Review and evaluate accuracy of MedDRA coding terminology assignments to adverse events/reactions, medical history and other safety data and correct assignments
  • Collaborates in identifying staff training needs and performs staff training on the use and understanding of the dictionaries (MedDRA and WHODrug)
  • Manages all dictionary upgrades and data mapping projects
  • Work with Thesaurus Manager to promote consistent operations, efficient use of resources, and knowledge sharing / best practices
  • Support management of CDM shared services in achieving common goals
  • Provide dictionary management support in general and to respond to Health Authority queries
  • Oversee production statistics and work on areas that require action
  • Work with HR to address any employee issues as well as timely action on HR related documentation
  • Provide feedback to Team for quality and efficiency improvement and ensure necessary corrective measures are taken

Clinical Data Coordinator

Quintiles Technologies (India) Pvt. Ltd.
01.2007 - 06.2009
  • Serve as Lead Coder on multiple studies with fewer than 5 operations staff or serve in a leadership role to a specific DM Task
  • Manage delivery of projects through full data management study life-cycle (with minimal guidance)
  • Manage project timelines and quality (with guidance from DTL or Manager)
  • Determining resource needs (with guidance from DTL or Manager)
  • Perform comprehensive data management tasks including data review, writing and resolving data clarifications
  • Perform comprehensive quality control procedures for coding specifications
  • Solves issues through using the global issue escalation/communication plan
  • Coding of Clinical Data using the dictionaries MedDRA and WHODD
  • Performance of data management tasks including discrepancy review, query generation and updating, quality control procedures for studies
  • Preparation of Data Management Documents mainly Data Coding Guidelines and SAE Reconciliation Guidelines
  • SAE Reconciliation, guiding DE personnel in CRF issues

Product Specialist

Taiba Pharma
Muscat
08.2005 - 12.2006
  • Responsible for Government Tender Business (Ministry) & Private market Business
  • Taking care of registration of new company and products in the country
  • Responsible for import of Pharmaceuticals, Ministry Approval & Clearance and Supply of the same
  • Sales in-charge for Muscat
  • Responsible for promotion of Oncology, Hematology and cardiovascular products to the doctors and Pharmacists
  • Responsible for managing a group of 4 Sales Representatives and sales in the Territory

Associate Clinical Data Coordinator

Quintiles Technologies (India) Pvt. Ltd.
02.2005 - 07.2005
  • Got trained in overview of clinical data management, DMP review, Protocol Interpretation/Overview of Therapeutic Area Training & Review of eCRF with protocol, Data Validation/ Listing Review, Creating the Edit Checks (Data Validation Specifications) & DVS (Data Validation Specifications) Review, SAE Recon Process, Oracle clinical and InForm Platform and related Trainings, Coding of Clinical Data-Introduction to the Coding Process, Database Lock / Unlock

Pharmacist Cum Executive Documentation

Lotus Lab India Pvt. Ltd.
Bangalore
01.2004 - 01.2005
  • Keeping track of the clinical supplies received, compounding and Dispensing of drugs, archiving drugs and returning the remaining excess supplies after study completion
  • Maintenance of various source data like: Pharmacy access book, Log book, Temperature and Humidity log books
  • Assisting in all documentation activities and knowledge of documentation procedures for regulatory filing (DCGI, European and USFDA submission)
  • Making protocols for conducting bioequivalence studies for clinical trials in accordance with GCP ICH guidelines on various dosage forms like tablets, Capsules, Suspension, and fixed combinations
  • Mainly involved in documenting all procedures involved in various stages of BA/BE starting from protocol preparations to report making and providing Quality check to final reports and protocols
  • Preparations of SOP of Pharmacy and giving training to the staff involved in the study
  • Awareness of ICH GCP and FDA guidelines for clinical trials

Education

Masters Diploma in Business Administration -

IIPM
Lucknow
01.2009

Bachelor of Pharmacy -

Government College of Pharmacy
Bangalore
01.2004

Diploma in Pharmacy -

Government College of Pharmacy
Karnataka
01.2000

Skills

  • MS Word
  • Excel
  • Power Point
  • Lotus Notes
  • Microsoft Outlook
  • Lync/Skype

Affiliations

  • Registered Pharmacist of Karnataka State Pharmacy Council
  • Certified MedDRA Coder

Additional Skills

MS Word, Excel, Power Point, Lotus Notes, Microsoft Outlook, Lync/Skype, English, Hindi, Kannada

Other Relevant Information

  • Actively Participated in Clintec's ICH-GCP workshop held at Bangalore.
  • Undergone 150 hours of Industrial training at AstraZeneca, Bangalore (in various departments Q.C, Q.A, Tablets & capsules, Liquid orals, Aerosols, Parenteral).
  • Undergone training on 'Pharmacist as a Human Resource Development' organized by Rajiv Gandhi University of Health Sciences, Bangalore.
  • Attended DIA pharmacovigilance conference in 2013.
  • One of the Expert Panelist of UMC conference held in Bangalore, India in Feb 2015.
  • Attended MedDRA and UMC conference held in Bangalore, India in Feb 2017.
  • Attended SCDM single day conference in Bangalore, India in Jul 29, 2017 and two day SCDM conference in 2022.
  • Speaker at the MedDRA and WHODrug user group Meeting, Bangalore in 2018.
  • Speaker at the WHODrug user group Meeting, Bangalore in 2021.
  • Programme committee member for MedDRA and WHODrug user group Meeting for India.
  • Recognized as one of the Top 20 Most Influential Data Champion at the 2nd Edition Data World Awards.
  • Speaker at ISCR conference on the topic 'Latest technology tools for clinical coding' in Feb 2023.
  • Panelist at ISCR on the webinar 'Awareness Session on Introduction to Clinical Trials and Career Opportunities' conducted on 06/06/24.

Timeline

Associate Director, Medical Coding

Fortrea
07.2023 - Current

Associate Director, Medical Coding

Labcorp Drug Development India Private Limited
10.2020 - 06.2023

Senior Manager, Data Management (Coding)

Covance India Pharmaceutical Services Private Ltd
10.2016 - 09.2020

Manager, Data Management (Medical Coding)

Chiltern India Pvt. Ltd.
09.2014 - 09.2016

Manager, Dictionary Management and Medical Coding

Theorem Clinical Research India Pvt. Ltd.
08.2014 - 08.2015

Business Advisor Specialist

Accenture Services India Pvt. Ltd.
01.2012 - 07.2014

Team Lead (Medical coding Specialist)

Accenture Services India Pvt. Ltd.
07.2009 - 12.2011

Clinical Data Coordinator

Quintiles Technologies (India) Pvt. Ltd.
01.2007 - 06.2009

Product Specialist

Taiba Pharma
08.2005 - 12.2006

Associate Clinical Data Coordinator

Quintiles Technologies (India) Pvt. Ltd.
02.2005 - 07.2005

Pharmacist Cum Executive Documentation

Lotus Lab India Pvt. Ltd.
01.2004 - 01.2005

Masters Diploma in Business Administration -

IIPM

Bachelor of Pharmacy -

Government College of Pharmacy

Diploma in Pharmacy -

Government College of Pharmacy

Similar Profiles

CREATE PROFILE
Rajiv Kumar Rai