Shamma Rajan

About Shamma Rajan

At the forefront of clinical study data management at Novartis, my role as a Senior…

Experience

1. Expert Clinical Data Scientist Trial Data Manager

   诺华

   Dec 2021 — Present · 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.

Education

• Loyola Academy, Secunderabad, India

  Master of Business Administration (MBA)

  2006 — 2008

• University of East London

  Master of Science (MSc)

  2009 — 2011

• St Francis College for Women, Osmania University

  Bachelor of Science (BS)

  2002 — 2005

• Clinovex Research Solutions

  Diploma in Clinical Research Management

  2014 — 2014

Skills

• Molecular Biology
• Western Blotting
• Clinical Data Management
• Negotiation
• Public Speaking
• Lifesciences
• Protein Assays
• Spss
• Sds Page
• Customer Service
• Pharmaceutical Industry
• Standard Operating Procedure (Sop)
• Microsoft Office
• Outlook
• Biostatistics
• Rna Isolation
• Cell Culture
• Bioinformatics
• Ctms
• Assay Development
• Life Sciences
• Windows
• Biotechnology
• C++
• Sql
• Hplc
• Molecular Genetics
• Photoshop
• Gcp
• Data Analysis
• Clinical Trials
• Teaching
• Html
• Clinical Research
• Gel Electrophoresis
• Ich Gcp
• C
• 21 Cfr Part 11
• Java
• Microsoft Word