Richa Morajkar
Hyderabad
Summary
Accomplished Clinical Data Management professional with over 16 years of experience leading end-to-end data management activities in global clinical trials. Proven expertise in EDC systems (Rave, Inform, OCRDC), database development and data validation. Adapt at streamlining data workflows, ensuring audit readiness, and delivering high-quality data for regulatory submissions.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Lead Clinical Data Manager
Tata Consultancy Services
Hyderabad
12.2014 - Current
- Performing end-to-end clinical data management activities (start-up, conduct, and close-out) for global clinical trials across multiple phases and therapeutic areas.
- Authoring and maintaining key study documents (eCRF design specification, Data Validation specification, Data Management Plan, CRF Completion Guidelines, and Data Review Guideline), ensuring GCP and SOP compliance.
- Conduct meetings with the Sponsor team, coordinate with stakeholders, perform quality checks, manage queries, and ensure a clean database for database lock with zero audit findings.
- Create, review, and maintain all essential TMF documentation.
- Configure reports in RAVE (BO4 Reports) as per the clinical team's requirements.
- Designated trainer for TCS/Client-specific processes, developed training materials, and best practice documents.
- Supervised a team of five CDMs; conducted performance reviews, mentoring, and project allocations.
- Offered Clinical Data Management (CDM) subject matter expertise to IT/Product teams toward the development and enhancement of TCS's in-house platforms for CDM.
- Supported multiple RFPs, provided estimations of efforts and budgets for CDM activities.
Data Analyst
Cognizant Technology Solution
Mumbai
10.2010 - 12.2014
- Performed database conduct activities (data review and query management) on Inform and Rave.
- Performed a database audit weekly as a part of quality control, and ascertained appropriate action on defects.
- Provided job process-related training to newly hired employees and guided them while on production.
- Contributed to and supported process improvement initiatives for the BIC project.
- Involved in/volunteered for organizational activities for team-building initiatives.
Data Manager
Karmic Life sciences Pvt Ltd
Mumbai
10.2008 - 10.2010
- Performed end-to-end data management activities, including database design, testing and validation, CRF tracking and reconciliation, double data entry, data verification, discrepancy management, and database lock/unlock on the ClinTrial database.
- Created and circulated a data management-related monthly dashboard to the internal DM head and team.
- Acted as a main point of contact for DM operations to ensure adherence to standards, quality and timely delivery.
Education
MBA - Operations Management
Institute of Chartered Financial Analysts of India (ICFAI)
05.2013
B.Sc. - Chemistry
University of Mumbai
05.2007
Skills
- Attention to Detail & Data Quality
- Regulatory & CDM Standards Knowledge
- Proficiency with CDM Tools & Systems
- Data Cleaning, Validation & Integration
- Communication & Collaboration
- Time Management & Organization
Certification
- Advance Certificate Course in Clinical Research
CMH Collage, Ulhasnagar
Accomplishments
Star performer
Tata Consultancy Services
12/2024, 10/2024, 01/2021, 06/2019, and 09/2015
Opel Award
Cognizant Technology Solutions
Mar 2013
Outstanding Performance Award
Karmic Lifesciences
May 2009
Languages
English, Hindi, Marathi, Telugu (Learning)
Timeline
Lead Clinical Data Manager
Tata Consultancy Services
12.2014 - Current
Data Analyst
Cognizant Technology Solution
10.2010 - 12.2014
Data Manager
Karmic Life sciences Pvt Ltd
10.2008 - 10.2010
MBA - Operations Management
Institute of Chartered Financial Analysts of India (ICFAI)
B.Sc. - Chemistry
University of Mumbai
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