Manojkumar Challuri

About Manojkumar Challuri

At Novartis, my 14 Years expertise in CDISC-SDTM standards propels the global harmonization of clinical trial data, ensuring quality deliverables across complex therapeutic areas. Contributing to Novartis\' mission, my role encompasses developing and maintaining critical data standards, facilitating effective communication with partners, and implementing strategic data changes.With a solid background in clinical data management and a focus on CDISC-SDTM mapping, my work involves leading robust impact analyses and executing action plans to optimize data acquisition and tabulation. Our team\'s collaborative efforts have significantly advanced data accuracy, empowered streamlined clinical trials, and supported the continuous evolution of patient-centered treatments.

Experience

1. Senior Clinical Data Standards Specialist

   Novartis

   May 2017 — Present · Hyderabad, IN

   Lead and contribute to Clinical Data Standards planning, definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.• Serves as the primary contact for global data acquisition and tabulation standards for core global and/or assigned high complexity Therapeutic Area ensuring timely and quality deliverables.• Evaluate and implement Clinical Data Standards changes and change requests conducting robust impact analysis and implementing action plans where necessary.• Communicate effectively with the partners and customers, establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.• Responsible for leading and supporting the technical implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing support to business users and teams on their use and supporting the implementation of the Clinical Data Standards strategy.• Expert technical support ensuring the implementation and timely availability of consistent, high quality Clinical Data Standards deliverables across global libraries supporting the Data Acquisition and Tabulation standard of Clinical Trial data including Data collection tools in EDC (CRFs, edits checks, derivations) and data transfer specifications, associated standard metadata, business rules and guidelines.• Connect with Data Standards Governance Board, other clinical standards design (CSA) and/or members of the metadata team to discuss technical issues with implementation of approved collection & SDTM data structures. • Making sure alignment between CDMS Global Library Objects and Metadata Repository. • Good Knowledge of Novartis Data Clinical Standards, Data Models and its implementation for database and GLIB development

Education

• Kakatiya University

  B.Pharmacy

  2006 — 2010

• clinical Research Education and Management(CREMA)

  P.G.diploma in Clinical Research including Clinical Data Management & Pharmacovigilance .

  2010 — 2011

• St.jhons college of Pharmacy

  M.Pharmacy

  2012 — 2014