SUGANYA SELVARAJU

Setup Phase:

Initiating and handling study Kick off meeting and review meeting with clients/study team.

Interpretation of Protocol, ALS.

Reviewing CRF, Dynamic specification creation and review.

Creation of Edit Check Specification, eCRF Completion guidelines, Data Transfer Specification and Data Management Plan.

Setup process for tSDV.

Conduct Phase:

Query management, SAS and manual Review.

Report generation and sharing DM metrics to the study team.

Handling post production changes, updating required specifications, reviewing migration reports prior updating the changes into production.

Protocol Deviation reconciliation and PD log creation.

Reviewing coding files.

User access management.

Close-out Phase:

Performing DB Freeze and Lock activities.

Handled Interim Freeze/Lock activities.

Reports generation and Proc compare reports review.

Achievements:

Part of Quality Control team.

Been involved in process initiatives and SOP/templates creations.

Part of SME team for DM processes.

Part of Standard GLIB creation team.

Performing Database testing, Edit Check testing and Local Lab set-up testing.

Performing Integration testing for IRT set up studies.

Query management, SAS and Manual Listings

Perform external data reconciliation.

Perform Serious Adverse Event reconciliation.

Create and maintain study files and other appropriate study documentation.

Assist Data Management Study Lead in development of eCRF, Data Validation Specifications, and Study Specific Procedures.

To assist with the training of less experienced Clinical Data Coordinators.

Serve as a resource for projects, deliverables, and improvement initiatives in the Data Management department.

Perform data management activities to ensure the generation of accurate, complete, and consistent clinical data, and support timely project delivery to the highest quality.

Ensure all activities are conducted in accordance with Good Clinical Practices (GCP), applicable SOPs, client requirements, and departmental requirements.

Senior Clinical Database Tester

As a POC, maintains and completes study documentation, both internal and sponsor specific to have a track on the study progress. All sponsor specific documentation to be delivered to the Study Team in a timely manner to enable inspection readiness at all times.

Works closely with other supporting departments to ensure all testing issues are resolved in a timely manner and study timelines are met.

Completes assigned tasks within the committed timelines and reports any quality issues to the study team in a timely manner. Flexible in handling multiple study projects at the same time, delivering with quality within the stipulated timelines.

Attends sponsor audits and assists with in-progress audits, as needed. Participates in and contributes to internal team meetings to share knowledge and provides latest update/features.

Participates in Data Management department initiatives. Contributes to training materials on a process, system or technology level.

Act as a trainer/mentor to new or less experienced associates on specific task(s). As part of guidance, reviews and ensures the delivery of new personnel within the team.

Maintain records for all assigned projects and archiving of trial / project analysis and associated documentation. Support special projects of limited scope (sub team lead, local project, etc.).

Clinical Database Tester II

Uses technical, industry and interpersonal skills to complete the user acceptance testing of clinical systems utilized for the collection, management and reporting of clinical trial data.

Involves in testing the clinical study database pertaining to screens and study flow. Reviews specification documents created by study team and flag the inconsistencies.

Performs edit testing and test cases creation activities according to sponsor specific SOP's an appropriate regulation. Writes and executes test cases and reports test results accurately in a timely manner.

Reviews Listing Validation Specification document created by study team. Involve in creation, execution of test data and validates listing outputs as per the study/sponsor requirements.

Achievements:

Received Inspire Awards-

For handling multiple studies with stringent timelines and delivered with quality.

Forecasting the studies and delivered the Main set up and PPC before the timelines.

For providing codes for new timesheets in validation.

For verifying and delivered quality testing for listing in production.

For Collaboration & Team work.

Validation Lead:

Training new joiners as a part of their induction, delivering training as well as mentoring.

Handling IVRS/IWRS & ePRO set-up studies as validation lead,

Checking over the timelines and resource management.

Reviewing Pre-UAT documents- Risk Assessment, Test scripts, Validation documents, Traceability Matrix and providing approval on those documents.

Reviewing Post-UAT documents- Issue Log, Clinical test scripts, Supply Chain Study team test scripts to ensure the quality of UAT and providing approval for all the documents.

Ensuring the quality of the set-up and delivering the study as on agreed timelines.

Reviewing change management studies.

Achieving Go-Live Successfully.

Validation Author:

Handling IVRS/IWRS & ePRO set-up studies ,

Reviewing User Requirement Specification and Integration Addendum

Attending Kick off meetings

Creating Project Plan, Risk Assessment, Validation Documents and Test Scripts

Scheduling Risk Assessment meeting and discussing bespoke items with all placeholders

Creating traceability Matrix

Conducting UAT, creating Issue Log and handling daily UAT meetings

Scheduling weekly study meetings with stakeholders

Managing study Emails effectively

Point of contact for Study team, vendors and Supply Chain team

Handling Change Management studies

Effective documentation of Validation activities

Participating in knowledge sharing sessions as and when applicable

Performing Operational QC as required.

Maintaining quality and timeliness of assigned studies

Achievements:

Received 2 Spot Light Awards- Efficiently handled back to back Main set-up’s and achieved Go-Live successfully for Oncology, respiratory Infection Therapeutic area and Cardio Vascular & Gastro Intestinal studies.

Received Spot Light Awards- for handling highly complicated oncology study and achieved Go-Live successfully.

Received Unicorn Award- for mentoring new joiners and bringing them successfully on the production.

Provided process improvement on change management studies.

Handling Datalabs, Medidata Rave, Inform, Medrio and Oraclestudies,

Creating Test Plans for Discrepancy checks, Dynamic checks, Listings and custom functions.

Executing Test Plans.

Generating reports in J review and PL/SQL.

Tracking results of Test Cases in the appropriate system.

Providing appropriate notifications and feedback on the results of testing.

Creating Test plans for IWRS studies.

Performing UAT for IVRS/IWRS studies.

Actively participating in internal meetings and global meetings.

Assist with the creation and maintenance of Acceptance Testing documentation.

Have created guidelines and process improvement documents for EDC tools.

Provided training for new joiners on IVRS/IWRS, dynamic, listing and edit checks.

Accomplished on peer review.