Adithya Bare

About Adithya Bare

Comprehensive knowledge of the procedures and clinical practice standards of Federal Drug Administration • Good Knowledge on Schedule -Y • In-depth knowledge of the processes of clinical data management systems, clinical trial methodology, GCP and medical terminology • Hands on training in clinical data management software oracle clinical 4.6 and real time experiance in InDesign CS 5.5 • Trained on CRF design • Good knowledge in SAS programming in clinical domain • Thorough understanding on drug development process • Good understanding on roles and responsibilities on study personnel in clinical data management • Ability to understand protocol and its components • Ability to prepare database structure document, edit check specifications • Thorough understanding on all phases of clinical trial • Good communication and presentation skills • Possess strong organizational and time management skills • Ability to work under pressure and meet deadlines • Good knowledge about CDISC and its standards • knowledge in computer operating skills

Experience

1. Sr Cda

   Syneos Health

   Oct 2022 — Present · Hyderabad, IN

   Reviews and adheres to the requirements of study-specific Clinical Data Management Plans for assigned project(s). • Creates and enters test data for User Acceptance Testing (UAT) • Performs User Acceptance Testing (UAT) for data entry screens, edits, and assigned data review listings, all different roles used in the study. • Receives and enters lab normal ranges. • Completes and submits Clinical Database Management System (CDMS)-specific access forms and/or spreadsheets. • Performs reviews of discrepancy (edit check) output and validation listings based on data entered into the clinical database. Based on this review, queries or applies self-evident corrections in cases where queries are not required, per the Data Validation Specification (DVS) and/or Data Management Plan (DMP) for the assigned projects. Resolves answered queries correctly and re-queries where appropriate. • For paper studies, ensure all CRFs and DCFs received are returned for filing in the Document Control Room per the Data Tracking Guidelines for the assigned projects. • Participates in internal meetings and internal/external audits as required. • May provide training on data management activities and systems. • Run data cleaning and/or status reports. • Performs Serious Adverse Event (SAE) reconciliations. • Vendor reconciliations • Coordinates the work of CDAs assigned to the project- Provides training on data management activities and systems- Provides project-specific training to other Clinical Data Associates (CDAs). • Actively coordinated PPC and implemented all the required changes as per the SOPs and WIs • Preparation of Mock listings for programming • Completes tasks within the timeframe by appropriately prioritizing multiple tasks within or across projects and adapts to timeline or priority changes by reorganizing daily workload. Runs data cleaning and/or status reports.

Education

• Avanthi Degree and Pg College

  Bachelor of Science (B.Sc.), Bio Chemistry

  2007 — 2010