Technical Support Service
Resume:
Vijaytha Arimbat Vishwanathan
*****, ********** ******* ***, *********,
North Carolina - 28215
Email: **********@*****.***
Mobile: +704-***-****
Summary
Having around 13 years of experience in the field of Information Technology– Involved in CTMS Application Testing, Specialized in Finance components, Operational System Support for Clinical applications on Development and Production environments and Client Support.
Lead team and trained them on CTMS application functionalities and conducted multiple workshops and product demonstrations on application process, system control and computations etc.
Responsible for managing several concurrent high visibility customers facing projects using AGILE methodology in a fast-paced environment.
Excellent knowledge in CTMS application (Oracle Siebel 8.0).
Single Point of Contact (SPOC) for Ticket queue management system. Assist the end users with necessary support (Identify, troubleshoot, escalate/resolve uncommon software issues) according to ITIL best practices using an IT Service management application to handle and document all requests.
Involved in set up, maintain, validate, and provide technical support for clinical systems for assigned projects in Clinical Trail Management System – CTMS.
Strong Experience and knowledge in Validation Plan, Test Summary Reports and User Test Scripts (PQ) based on the requirement specification.
Working in a global team environment to troubleshoot and resolve clinical application and clinical system issues.
Good knowledge on SQL and data model configurations.
Experience in Siebel Admin, Configuration and Computations.
Interaction with Project Managers, other Testers and collaborate with functional Analysts, developers, Interface (EDC/IVR) Team and business teams to communicate problem impacts and to understand the business requirements.
Performs the role of liaison between end users and IT support teams.
Track and document defects, deviations and incident management reports.
Participate in requirement analysis discussions, user testing of new enhancements and review of associated procedures, training and documentation as assigned.
Analyze the Support requests logged in Service Now for Clinical systems and provide the necessary solution and status details like closed / resolved, re-assigned or escalated as appropriate. Facilitate and provide end-user training on CTMS Finance application. Page 2 of 4
Technical Skill Set
Products
Clinical trial management system (CTMS or ECLIPSE, My Trials, Electronic Trial Masters Filing System - Veeva, Elvis, Wingspan).
Tools JIRA, Service Now, Peoplesoft, Quality Center Platforms MS Word, Excel, PowerPoint, Tally
Database SQL & PLSQL
Technologies OBIEE Reports
Educational Qualification
2002-2005 Bachelor of Commerce
Sri Sai College for Women’s affiliated to Bangalore university Professional Experience
Company Designation Duration
IQVIA, Brussels, Belgium
Senior Records Management
Associate
From 03 Dec 2018 to Oct
2019
Novellas Healthcare (Working for Bristol
Myers Squibb), Brussels, Belgium
Protocol Specialist
From 07 May 2018 till Oct
2018
Quintiles Technologies India Private
Limited., Bangalore, India
Integrated Processes &
Technologies Specialist- I/II
From Dec 2010 to May 2017
Project details
IQVIA, Belgium Senior Records Management Associate Responsibilities
Provide effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures. Including use of scanning equipment.
Perform image/scan processes and train imaging/scanning processes.
Sort and classify coded material for filing. Create files according to established classification system.
Maintain log and enter metadata in database to track status and facilitate accurate retrieval of information.
Maintain files and process reports, collections, and validations.
Maintain logs and indexes to provide status of information and assist in the collection of data for preparation of monthly metric reports.
Assist in the training of new team members on departmental procedures. Project details
Novellas Healthcare (Working for
Bristol Myers Squibb), Belgium
Protocol Specialist
Responsibilities Assisting the clinical team in country planning and protocol level milestones and Page 3 of 4
drivers in Eclipse.
Collaborates with the Protocol Manager to ensure complete review of protocol level listings as outlined in the data review plan.
Responsible for process/stakeholder management for study set up and execution
(e.g., project tracking, vendor set up, cost plan requests and invoice tracking).
Assist the clinical team in the development and collection of study level documentation.
Assisting Study team with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
Proactively take the appropriate relevant actions to address gaps, issues and risks and make suggestions for improvement.
Assists project staff in tracking that essential documents are received and maintained across assigned studies and sites.
Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Policy & Procedures, FDA and ICH GCP guidelines.
Participate in organizational process improvements as required.
Maintains a computer database of all filed documentation to ensure fast retrieval of documents.
Assists with maintaining up-to-date study status tracking and other tracking tools
(as assigned).
Collaborated with CRAs to ensure support for the collection and tracing of documents.
Ensured customer requests for retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner.
Assists with activities for off-site archival of clinical and TMF records.
Set up, organize, and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
Contacting clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.).
Project details
Quintiles Technologies India Private
Limited., Bangalore, India
Integrated Processes & Technologies Specialist- I/II Responsibilities
Set up CTMS for assigned studies, acts as "super User" for assigned studies, update, and reviews data for consistency. Manages vendors and associated data. Manages vendor and site-specific documents, contracts, and payments throughout the study.
Analyze the Support requests logged in Service Now for Clinical systems and provide the necessary solution and status details like closed / resolved, re-assigned or escalated as appropriate. Facilitate and provide end-user training on CTMS & Finance application.
Involved in set up, maintain, validate, and provide technical support (SOPs, Page 4 of 4
protocols, technical specifications) for clinical systems for assigned projects in Clinical Trail Management System – CTMS.
Involved in system set up (Study, Country, Site, Contacts, Accounts, Create and set up templates such as Subject Visit Templates, Investigator Grant Set-up, generate OBIEE finance & status reports), maintain, validate and provide technical support to project teams for assigned projects in Clinical Trail Management System – CTMS.
Provide end-user training on CTMS Finance application.
Working closely with development and business teams to communicate problem impacts and to understand business requirements. Also, worked closely with Product Management and Production teams on enhancements to understand business requirements and communicate problems/impacts if any.
Act as first line of support for Investigator Payment Analysts (IPA SUs) and Host & Support Finance walk-through calls.
Create Validation Plan, Test Summary Reports and User Test Scripts (PQ) based on the requirement specification.
Interacting with sites for payments related issues and assisting CRA’s and CPM’s.
Maintaining the patients Profile by updating the system and running various Finance reports and Patient Information’s.
Responsible for granting access to the new users (CRA/CTA/LM/CTL) according to their role in the projects.
Generating payment batch reports & release of Investigator Payment to Sites.
Ticket queue management and Improvement in ticket escalation process. Role Clinical Trial Assistant (CTA)/Senior CTA
Duration Feb-2006 to Nov 2010
Ce
Certifications
Barnett Accreditation - Fundamentals GCP EXAM for support staff, on October 1st., 2012
Information Technology Infrastructure Library (ITIL Foundation - 2011), 2016 Personal Details
Date of Birth : 14th Jan 1984
Sex : Female
Marital Status : Married
Nationality : Indian
Passport No : P8165952
USA Visa Status : L2 EAD
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