NIRMALA JAMES
Bangalore
Summary
With overall 9 years of experience and 6 years of experience in clinical research domain, dynamic Technical Designer with proven expertise at IQVIA in database design. Adept at developing precise specifications and leading cross-functional teams to enhance clinical data integrity. Recognized for delivering high-quality outputs and fostering collaboration, ensuring project timelines are met while driving process improvements.
Overview
15
15
years of professional experience
Work History
Technical Designer
IQVIA
Bangalore
06.2023 - Current
- Interpreting protocols to identify programming needs for distinctive trials.
- Evaluate extensive requirements, gather relevant data, conduct comprehensive reviews, and generate accurate Data Validation Specifications for SAS checks and listings based on the Data Management Integrated Review Plan, vendor DTAs, trial-specific critical item list, medical review plan, endpoints checks, and protocol deviations.
- Review the requirements in Data4You, and create specifications to program check listings, signal detection listings, protocol deviation listings, tables, and graphs based on the data review methods.
- SDTM annotations mapping, Data Review Model Variable Mapping, and develop specifications.
- Support Validation Team leads, programmers, Data Team leads as needed, and contributed to the creation of test cases and data entry.
- Report project risks to Data Team Lead, highlighting potential timeline delays based on the Plan.
- Develop and build basic components of clinical databases, including forms and structure, data dictionaries, and unit dictionaries. Attend Impact Analysis Meetings to understand the requirements, changes, and updates.
- eCRF Data Validation Rule Specification Creation and Edit Checks Programming.
- Lead study activities, collaborate with cross-functional team members, and clients to review the business requirements, conduct peer review and train peers.
Project Associate
Cognizant Technology Solutions
Bangalore
10.2021 - 05.2023
- Engaged in kickoff meetings, understanding client requirements to develop clinical data visualization platforms.
- Perform testing activities, dry run testing, formal testing, alpha testing, and negative testing as part of Clinical Data Visualizations tool development.
- Developing test steps for edit checks.
- Designed SQL statements to support the verification of test cases.
- Recorded defects and worked alongside developers to address them.
- Validation Activities: Work with internal and external clients to analyze the requirement. Create data entry scenarios, data entry, write test cases, work closely with the programmer and Study Business analyst to generate the desired output for protocol deviations.
- Ensured output validation and identified discrepancies in TCL.
- Perform UAT, Unit testing.
- Review Change Impact Analysis document and make eCRF level study specific changes.
- Address UAT and post-production issues.
- Clinstore testing involved reconciliation between the Rave data and Clinstore data (storage) to identify discrepancies, such as differences in records, counts of records, and field differences between the Rave and Clinstore data identified.
- Complete assigned tasks within budget and timeline constraints, and report any quality issues to the lead or manager in a timely manner.
- Attend sprint meetings as a part of Agile methodology for project implementation.
Lead Medical Surveillance Specialist
IQVIA
Bangalore
07.2018 - 01.2021
- Experience in Data Management in the Lab data specialization and Medical Data Review during study start up, conduct, and close out.
- Monitor laboratory reports for all patients participating in the study, to ensure patients safety. Contact sites to obtain relevant medical history. Using the established guidelines, the site is instructed regarding the appropriate course of action such as requesting repeat testing, approving additional testing to determine subject eligibility or recommending the exclusion of subjects who are judged to be in appropriate for participation in the study. If the information obtained from the site and the action to be taken are not addressed in established guidelines. the IQVIA medical advisor is consulted for appropriate action.
- Conduct preliminary review of the local lab listings and local ECG listings and raise queries in EDC. Conduct a preliminary review of laboratory results relative to established protocols, specific reference range guidelines, using relevant clinical laboratory experience, and compare current results with prior laboratory values to evaluate or note clinically significant increases or decreases, and contact the investigator site for pertinent additional clinical contact for distribution to the project team.
- Based on clinical laboratory and monitoring experience identify potential significant trends and alerts IQVIA medical advisor.
- Interact with project team to convey critical information that may impact study objectives. Work with Central laboratory and local laboratory staff to facilitate appropriate monitoring and reporting of subject laboratory results.
- Worked on building medical monitoring plan during study startup and protocol presentation slides regularly for all the studies handled and kept updated team on the status of the protocol with refresher trainings.
- Lead the MSS project team involved in medical review of abnormal Labs and ECGs on a daily basis and serve as liase between the Medical Services Department and sponsor designated laboratory and the IQVIA project team.
- Peer review of daily outputs, provide summary outputs to stakeholders and good experience in training the peers and building the training materials.
Senior Process Associate
Envoy
Bangalore
03.2016 - 04.2018
- Communicate with patients, payers, and insurance to follow up and resolve claims.
- Work with the patient to set up payment plans, and confirm coverage and claim status.
- Process denials, refunds, appeals and claim status.
- Create reports and documentation for regulatory bodies, lawyers and other groups.
- Analyse database and contracts to make adjustments, report on current state and Research claim.
Process Associate
ALTISOURCE PORTFOLIO SOLUTIONS
Bangalore
01.2010 - 01.2012
- Processing vendor payment batches and Client billing files for all clients
- Providing accurate, complete and timely responses to e-mails and queries from internal and external stakeholders
- Reconcile and analyse exception reports within invoicing team and operational reports related to invoicing
- Analyse reports, provide recommendations and implement corrective action to improve processes
- Provide accurate and timely reports, and reconciliation during the end-of-month reporting to ensure timely submission of reports to the Accounting Team.
- Compile and coordinate reports (daily, weekly, monthly – based on client and business requests).
- End-of-Month reporting (consolidating, reconciliation, and preparation of month-end reports).
- Timely submittal of invoices on client platforms
- Participate in QA activities, and provide feedback.
Education
Advance PG Diploma in Cinical Research And Data Management - Clinical Data Management
Syncorp Training Institute
Bangalore04-2018
Master of Science - Biotechnology
Kristu Jayanthi College
Bangalore09-2009
Bachelor of Science - Biotechnology
Kristu Jayanthi College
Bangalore09-2007
Skills
- SQL
- Spotfire
- Rave edit check programming
- Specification creation
- Study Build
- Testcase and Testscript creation
- SDTM eCRF annotations
- Familiar with JIRA Toolset
- Knowledge in J Review
- Experienced with Veeva Vault Management
Accomplishments
- Received awards for the best performance and Quality work delivered from internally and externally by therapeutic medical advisor, Client and from quality team as well as the best performer amongst medical monitoring review team like Bravo awards, shout outs and Top Reviewer awards during my career as Lead Medical Surveillance Specialist
- Have exceeded expectations at multiple competencies level, and received appreciations from Data Team Leads for taking up complex requirements, and delivering outstanding quality work with precision and prompt delivery.
- Have been recognized and received Sapphire award for the efforts in the development and testing of clinical data visualization platform at Cognizant.
- Have independently led and handled multiple studies at different therapeutic levels, and have delivered complex specification within the forecasted timeline with exceptional quality and precision.
- Took initiative and created front end and Backend specification creation for edit checks and SAS checks for oncology and Immunology studies.
- Efficient Backlog Management: Optimized and managed specification development backlogs across multiple trials contributing to faster programming and completion of task as per the project plan.
Languages
Malayalam
First Language
English
Intermediate (B1)
B1
Kannada
Upper Intermediate (B2)
B2
Hindi
Elementary (A2)
A2
Tamil
Beginner (A1)
A1
Timeline
Technical Designer
IQVIA
06.2023 - Current
Project Associate
Cognizant Technology Solutions
10.2021 - 05.2023
Lead Medical Surveillance Specialist
IQVIA
07.2018 - 01.2021
Senior Process Associate
Envoy
03.2016 - 04.2018
Process Associate
ALTISOURCE PORTFOLIO SOLUTIONS
01.2010 - 01.2012
Advance PG Diploma in Cinical Research And Data Management - Clinical Data Management
Syncorp Training Institute
Master of Science - Biotechnology
Kristu Jayanthi College
Bachelor of Science - Biotechnology
Kristu Jayanthi College
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