Summary
Overview
Work History
Education
Skills
Knowledgedomain
Cocurriculars
Languages
Disclaimer
Databasesworked
Personal Information
Certification
Timeline
Generic

Gyan Ranjan

Bangalore

Summary

With a proven track record at IQVIA RDS India Pvt Ltd, I excel in database design and eCRF creation, adhering to CDISC standards. My expertise in C# and SQL, combined with strong leadership and innovative problem-solving skills, significantly enhances data management efficiency and accuracy. I am recognized for mentoring teams towards operational excellence, ensuring project success.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Senior Clinical Database Designer

IQVIA RDS India Pvt Ltd
06.2018 - Current
  • Serve as Subject Matter Expert (SME) for eCRF design, database design (Rave) in compliance with CDISC standards, listing specifications, custom reports, and Clean Patient Tracker specifications
  • Act as a Subject Matter Expert in supporting the implementation of new processes, data standards, training programs, systems, vendor quality assessments, audits, and inspections
  • Responsible for ensuring consistency in assigned trials with program-level standards by leading the technical implementation of industry (CDISC and regulatory) data standards, while providing expert consultation to data management and reporting areas
  • Lead the creation and management of standard libraries across different therapeutic areas
  • Oversee project resource forecasting and allocation, especially within a Functional Service Provider (FSP) environment
  • Develop eCRFs, design dynamics, and implement email alerts using custom functions (C#) in the Medidata Rave EDC system, adhering to protocol needs and regulatory standards
  • Manage the setup of project study databases using Medidata Rave Architect, ensuring alignment with client and protocol requirements
  • Participate in protocol discussions with sponsors and internal stakeholders to gather and finalize data collection requirements for database design
  • Ensure clinical data standards are consistently implemented to improve efficiency, productivity, and accuracy
  • Lead screen review meetings with study stakeholders, providing clear guidance on database design
  • Drive innovations and initiatives in Data Management (DM) to enhance quality, efficiency, and operational excellence
  • Lead the development and delivery of Edit Check Specifications and ensure the programming of study-specific checks
  • Create and oversee study-specific eCRF completion guidelines and specifications
  • Collaborate cross-functionally with project teams, including Data Team Leaders, Principal Programmers, and Validation teams, to ensure smooth and timely startup activities
  • Provide leadership and mentoring to the study team by allocating work, monitoring risks, and mitigating challenges to ensure timely database go-live
  • Communicate risks and challenges effectively to stakeholders, negotiating timelines and solutions as necessary
  • Mentor and train new resources on various start-up activities, conduct quality reviews of their work, and provide feedback before they begin live activities
  • Lead weekly client meetings to manage study updates and negotiations on deliverables
  • Generate and manage essential study documentation, including Data Management Plans (DMPs), Test Cases, and Comment Logs, ensuring compliance with SOPs and operating procedures
  • Guide the testing and validation of clinical databases by preparing test cases, validating reports, listings, and edit checks, and overseeing SAE reconciliation
  • Provide mentorship in test script creation, logic validation, and discrepancy rule understanding, while ensuring the execution of testing activities as per the project test plan
  • Document all testing activities and maintain study records in accordance with SOPs and regulatory standards, fostering a culture of continuous improvement and team collaboration

Data Analyst (Active Team Lead)

Cognizant Technology India PVT LTD
07.2016 - 05.2018
  • Review clinical trials data in accordance with Global Data Management Plans and applicable standardized data management processes to identify erroneous, missing, incomplete data and run ancillary programs (e.g
  • Special listings, reconciliation discrepancy listings) used to support the review of clinical trial data
  • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to database
  • Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application
  • Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third-party vendor data (eCRF, eDiary, specialty laboratory, etc.) and aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation
  • Apply quality control procedures and checks to ensure data quality standards (client and Covance) are achieved
  • Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, etc
  • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data
  • Assist in the development of the clinical data model and/or database design and annotate the CRF (eCRF) according to these specifications, the creation of data acquisition conventions and data review guidelines / edit check specifications consistent with the clinical data model, [statistical] analysis plans, and CRF (eCRF) completion / monitoring conventions and the development and testing of data management system edit / data validation checks and special listings / procedures used as tools for the data review and discrepancy management activities
  • Interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the setup, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality
  • Support the training of project staff on project-specific, global, standardized data management processes, maintain technical data management competencies via participation in internal and external training seminars and review literature and research technologies/procedures for improving global data management practices

Clinical data Associate II

PPD(India) Private Limited
10.2014 - 07.2016
  • Essential function is to perform all Clinical Data Management activities on assigned projects, commensurate with experience and/or project role
  • Carrying out the role of Conduct Data Review, raising and integrating queries, understanding of clinical coding concepts
  • Review of electronic data, SAE Reconciliation, SLAB Review
  • To be involved in database initiation, set up and Lock activities
  • Have taken responsibility of Batch ACPT and other project related documents
  • Have attended weekly call with the client and understand their requirement and deliver the task as per client need as well as update them on DM activities
  • Have trained the new team members on various CDM activities
  • Have shared my ideas for process improvement and prepared project related guidance documents
  • Have taken up SPOC role for CRF Unlock Request

Clinical Data Co-ordinator

Quintiles Research India Pvt Ltd
12.2010 - 10.2014
  • Understanding basic database structure and performing testing of Clinical Data Base
  • Experience in Test Script creation by understanding logic and discrepancy rule
  • Execute the testing activities as per the test plan
  • Experience in SAS manual listings validation and test data creation
  • Documentation of testing activities as per SOP/WI
  • Understand and comply with core operating procedures and working instructions
  • Meet objectives as assigned
  • Develop and maintain good communications and working relationships across teams
  • Solve issues using the global issue escalation/communication plan
  • Consult with Standards Group for process issues; bring up ideas for process improvement
  • Resource Planning
  • Performing Quality review and ensuring high quality output in testing
  • Coordinating with Validation Team, Validation Team Leads and programming leads
  • Assist in the maintenance of Data Management Study files

Education

M.Sc. - Biotechnology

Kuvempu University
01.2014

Post Graduate Diploma - Clinical Data Management

Institute of Clinical Research India (ICRI)
Bangalore
01.2009

B.Sc. - Biotechnology

Bangalore University
01.2006

10+2 -

Patna collegiate school
Patna
01.2000

Matriculation -

CBSE
01.1998

Skills

  • Programming Languages Known: SAS(Trained)
  • Programming Languages Known: C# certified, SQL developer
  • CDMS System in Clinical Research - Oracle Clinical (Version 45)
  • PMP : Trained
  • Windows 98/XP, Windows 7
  • MS-Word, Excel, PowerPoint
  • Internet browsing

Knowledgedomain

  • Clinical Research Operation, Documentation and Report Management
  • Clinical research operations and trials.
  • Clinical Data Management.
  • Managing the data of a clinical trial, stored in CDMS (Clinical Data Management System).
  • Understanding of Coding of Data and Coding Dictionaries, used.
  • Prepared Data Editing Guidelines and Designed SOPs (Standard Operating Procedures) for CDM (Clinical Data Management).
  • Good understanding of CDISC (Clinical Data Interchange Standards Consortium).
  • Good knowledge of 21 CFR Part 11 (21 Code of Federal Regulations Part 11).
  • Good knowledge of EDC (Electronic Data Capture) and Paper Technology, used in CDM (Clinical Data Management).
  • Good understanding of GCDMP (Good Clinical Data Management Plan), published by SCDM (Society for Clinical Data Management).
  • Good understanding of ICH-GCP (International Conference on Harmonization-Good Clinical Practice).

Cocurriculars

  • Recipient of various prizes in painting and recitation competitions at school level.
  • Participated in various sports (Cricket & Football) & outdoor activities.
  • Took part in Science Talent Examination and received certificate.
  • Took Part in Science Exhibition and Quiz Contest.

Languages

  • English
  • Hindi

Disclaimer

I hereby declare that above information is true to the best of my knowledge and belief.

Databasesworked

  • Oracle Clinical(Version 4.0.3, 4.5.1)
  • Inform(Version 4.6, 5.5 & 4.6.5.1)
  • RAVE(Version 5.6.0, 5.6.1)

Personal Information

Father's Name: Anirudh Kumar Shukla

Certification

  • Rave Medidata Certified
  • Foundational C# with Microsoft

Timeline

Senior Clinical Database Designer

IQVIA RDS India Pvt Ltd
06.2018 - Current

Data Analyst (Active Team Lead)

Cognizant Technology India PVT LTD
07.2016 - 05.2018

Clinical data Associate II

PPD(India) Private Limited
10.2014 - 07.2016

Clinical Data Co-ordinator

Quintiles Research India Pvt Ltd
12.2010 - 10.2014

M.Sc. - Biotechnology

Kuvempu University

Post Graduate Diploma - Clinical Data Management

Institute of Clinical Research India (ICRI)

B.Sc. - Biotechnology

Bangalore University

10+2 -

Patna collegiate school

Matriculation -

CBSE

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