Vinisha Sakthi Mahesh

MEDIDATA RAVE

• Have strong technical, industrial, and interpersonal skills to interpret clinical protocols and customer requirements in order to create clinical data management system (CDMS) designs including electronic Case Report Forms (eCRFs), dynamic eCRF functionality and eCRF edit checks to meet the needs of the customer and the clinical trial.
• Ability to independently assess impacts of post-production database related changes (CPPCs), communicate the risks and impacts of the migration, and execute both test migration and PROD migration for studies ensuring quality, without dataloss.
• Responsible for optimal design decisions and the utilization of CDASH/client specific standards.
• In-depth functional knowledge of Rave modules with experience in Core configuration setup, Lab modules, Coding module, Migration module including Object Hierarchy, linking CCG Guidelines to study, TSDV setup Reporting module, e-Learning module, User access requirements.
• Ability to plan and design CDMS components directly from interpretation of complex clinical trial protocols.
• Acts as the primary point of contact during study build for more complex questions by the project team.
• Tracks and keeps functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner.
• Ability to lead eCRF and other specification review meetings.
• Ability and willingness to assist team members.
• Strong written and oral communication and presentation skills.
• Strong inter/cross-team communication skills.

CLININFO

• Ability to interpret clinical protocols and customer requirements in order to build on study setup including EDC specification, Editcheck specification and eCRF specifications.

RAVE

• Excellent functional knowledge of Rave EDC systems with ability to create studies in URL from scratch, setting up the Core configuration of the URL and handling of complex Post-production changes.
• Acts as the primary point of contact during study build for assigned projects for design related questions by the project team.
• Ability to plan and design CDMS components (including Forms, Editchecks, Custom function directly from the requirements provided using prototyping methodologies as needed.
• Ability to handle complex Post production migrations with providing an Impact Analysis and Risk Assessment of the proposed changes.
• Ability to work on multiple components including TSDV setup, Coding module, Lab module, Core configuration setup, Reporting module, e-Learning module, User access requirements.
• Creates and maintains standard libraries for all study components.
• Strong written and oral communication and presentation skills.
• Strong inter/cross-team communication skills.

DATATRAK (now Fountyn)

Ability to work on simple setup study in Datatrak following the specifications as per the protocol.

Client : Abbvie

Role: Standards Support Personnel, Data Sciences

Team: Standards Team (Lead for a team of 3 members)

Handled Global Library - building standard editchecks and custom functions, approve requests, build fields in the Global Library, analyse and update the workings

on GLib. Upload variables to database in MDR

Role: EDC System Analyst

Team: Migration Team

Handled over 150+ Amendment study requests that include building forms,

editchecks, custom functions, deleting forms, updating dynamics, merging forms,

moving data from one field to another and other migration activities.

Handled various Medidata tickets

Provided support to Data Analysts for resolving issues faced in subjects in PROD

environments and performed programming fixes for many studies.

Role: EDC System Analyst

Team: Development Team

Built 3 Phase III Oncology and Immunology studies from scratch (include building

fields, forms, editchecks and all the dynamics associated with it)