Mahendra Reddy Challa
Summary
With over 10 years of experience in clinical data management and project management, successfully supporting the startup, conduct, and close-out phases of clinical studies across Phase I, II, and III. Expertise in designing eCRFs using CDISC/CDASH standards, ensuring protocol compliance, and utilizing advanced analytical, reasoning, and problem-solving abilities. Proficient in accessing and manipulating database systems to ensure data integrity and reporting. Proven track record in overseeing Data Management teams, external vendors, and CROs to ensure adherence to regulatory guidelines, GCP, and internal policies.
Overview
10
10
years of professional experience
Work History
Project Data Manager
Syneos Health
08.2022 - Current
- As a Lead Data Manager responsible for delivering data as per project timelines, ensuring high-quality data for clients across multiple therapeutic areas
- Oversee project management and team coordination, including resource allocation, task assignment, and timely delivery of project milestones
- Create and validate data structures in line with project requirements, including designing and implementing database setup activities for Veeva Vault and Medidata Rave
- Develop and manage key project documents, such as Data Management Plans (DMP), Data Validation Specifications (DVS), and Edit Check Specifications
- Maintain ongoing communication with study teams and clients, coordinating regular updates and ensuring alignment with study objectives
- Serve as the Subject Matter Expert (SME) for data management processes, driving process improvements and initiating best practices across projects
- Create programming reports from source data for regulatory submissions and analysis, ensuring compliance with internal and external standards
- Developed comprehensive training materials for team members, resulting in increased proficiency and productivity.
- Negotiated contracts with external vendors for cost-effective data management services without compromising quality standards.
- Mentored junior staff members, providing guidance on career development opportunities and promoting professional growth within the team.
- Optimized database structures for faster query processing and increased overall performance.
Senior Clinical Data Manager
Syneos Health
08.2018 - 08.2021
- Led data management teams, overseeing the timely delivery of clinical data while ensuring adherence to timelines and quality standards
- Served as the primary point of contact for Sponsors and cross-functional teams, fostering strong communication and collaboration
- Worked as a technical designer, ensuring the correct implementation of data management processes and technical specifications
- Acted as the UAT Subject Matter Expert (SME), managing user acceptance testing and driving process improvements for efficient data flow
- Initiated process improvements and played a key role in developing and optimizing workflows within the data management team
Clinical Data Manager
Novartis Healthcare
04.2017 - 08.2018
Clinical Data Coordinator
Quintiles India Pvt. Ltd.
11.2014 - 03.2017
Education
Master’s in Pharmacy - Pharmacology
JNTUA
INDIA01-2014
Bachelor in Pharmacy - Pharmacy
JNTUA
INDIA05-2011
Skills
- Clinical Data Management End to End
- ECRF Design from Standards
- EDC tools-RAVE and Veeva
- Protocol Compliance
- Study EDC Start-Up Activities
- User Acceptance Testing
- Discrepancy Management
- Data Integrity
- Data Cleaning and Data processing
- Data Modeling
- Data Validation
- Vendor Management
- Safety data Management
- SQL
- SDTM
- SAS
Domain technical skills
EDC tools: Medidata Rave, Veeva Vault, InForm, Veeva CDB, OC-RDC (Oracle Clinical Remote Data Capture)
Data Review Tools: Spotfire, JReview,
Tumor Evaluation: RECIST1.1 and iRECIST
Data Programming Tools: SQL, SDTM, SAS
Therapeutic experience
- Oncology, Phase II, III
- Cardiovascular, Phase III
- Ophthalmology, Phase I & II
- Immunology, Phase II
- Vaccines, Phase II, III
Languages
English
Bilingual or Proficient (C2)
Telugu
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
German
Elementary (A2)
Timeline
Project Data Manager
Syneos Health
08.2022 - Current
Senior Clinical Data Manager
Syneos Health
08.2018 - 08.2021
Clinical Data Manager
Novartis Healthcare
04.2017 - 08.2018
Clinical Data Coordinator
Quintiles India Pvt. Ltd.
11.2014 - 03.2017
Master’s in Pharmacy - Pharmacology
JNTUA
Bachelor in Pharmacy - Pharmacy
JNTUA
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