Shamma Rajan

Expert Clinical Data Scientist Trial Data Manager @诺华

Hyderabad, IN

Lead all the data management aspects of a clinical study and ensure that study level deliverables are completed on time, with quality, and in accordance with corporate and regulatory requirements and managing staff responsible for performing those activities.Develop/update DM documents including, but not limited to, Data Management Plans, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, and Data Review Plans.Demonstrate collaboration and relationship-building with all study team representatives (e.g. Biostatisticians, Statistical Programmers, Medical Monitors, Clinical Project Managers, Clinical Trial Managers, CRAs, Clinical Pharmacologists, Biomarker/Bioinformatics scientists, Medical Writers, Regulatory representatives, etc.).Lead the development of specifications, implementation, and testing for the eCRF, edit checks and data review and oversight listings (DVS).Set up and maintain data management study files for inclusion in the Trial Master File, ensuring these are maintained in an audit ready state for review.Organize and lead regular data management team meetings, internal stake holder meeting, external vendor meetings along with maintaining and tracking meeting minutes, issues and decisions logs, and escalations to ensure smooth running of the trial.Review the Pinnacle 21 issues to make sure the issues are addressed in both data cleaning and programming related by making necessary changes via PPC.

Loyola Academy, Secunderabad, India

Master of Business Administration (MBA)

University of East London

Master of Science (MSc)

St Francis College for Women, Osmania University

Bachelor of Science (BS)

Clinovex Research Solutions

Diploma in Clinical Research Management