Dr Abhishek Joshi, Ccdm® Email & Phone Number

Boston, Massachusetts, United States

Hyderabad Area, India

Hyderabad Area, India

Hyderabad Area, India

Provide professional DM input on Clinical Trial Team(s) Input to and review of clinical trial database design including User Acceptance Test-ing (UAT). Provide input for the Validation and Analysis Plan (VAP) meeting for the clinical trial, which includes taking an active part in the meeting, providing input in writing the study specific validation checks and necessary reports to ensure high quality and consistent data. Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks. Review and contribute to preparation of protocols, specifically related to the data management section, visit schema and study design with supervision. Prepare Case Report Forms (CRFs) and CRF completion Guidelines (CCGs), electronic or paper. Perform the reconciliation of Serious Adverse Events (SAE's) coordinating with the site as well as the safety team.Support and assist data management staff for allocated trials. Freeze and lock data as appropriate in time for statistical review, blinded interim quality review, interim and final database lock. Perform training on data management software and practices or trial specific topics as required. Participate in preparation of training materials for data management activities and processes.Perform reconciliation of third party (Lab, ECG, IVRS etc.) data as per the Data Transfer Specification

Bengaluru Area, India

It involves ensuring a clean lab data results in both CRF and vendor results.Involves addressing issues with regard to test code update, assign lab site ids, LAC'ing, performing self evident corrections. To have a clear understanding of the protocol study matrix and resolving issues related to collection date and visit date. To query for incorrect differential or missing units, missing metadata information higher and lower values compared to acceptable ranges and perform lab extreme checks.Analyze lab demography results.Search in electronic repository for normal range documentation and report it in a spreadsheet to be sent to Normal range team.Analyzing ECG data.Designated as the Clinical Lab Expert by the onshore team and is responsible of any clinical analysis of an analyte.Role as External Data Operations - Loader

Bengaluru Area, India

It involves ensuring the completeness of clinical trial data after it has gone through data entry. Ability to address validations and perform various manual checks. Also have a clear understanding of Lab Data and coding issues. Thorough knowledge of discrepancy toolset and oracle clinical database. Have a understanding of issuing Data clarification forms to the clinical sites and also updating them maintaining SLA. Delivering clean patients after addressing issues with 100% quality.

Review and load data sent from vendors to Client via an electronic transfer, into the Oracle Clinical Database through the Client Data Loading System.Coordinates across multiple protocols and/or programs, the loading and technical review of electronically-sourced clinical data.Works independently to ensure that all EDO data loading activities for a protocol have been effectively and timely performed from protocol development to database lock

Pgd In Bioinformatics, Bioinformatics

Surgery And Medicine