THARSILA AROKIASAMY

Responsible for Clinical data Validation, Query generation and Integration.

Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings(Lab, SAE, ePro, eCOA, Pk &PD Reconciliation)

Primary contact for client DM/study teams/clinical team for all data management related study enquiries.

Primary contact for quality deliverables across setup/conduct and closeout phase by frequent meetings with Client and Third-Party Vendors.

Generate, review for accuracy and distribute status reports as requested. CPT review. UAT, Specification writing, test scripts creation.

Perform quality review for new resources, Organize teleconference and team meetings, and Project documentation for Audits.

Participated in Study Kick Off meetings and all study related meetings till study Close-out to track data management activities and ensure project milestones are met according to agreed timelines with high quality.

Provided guidance to the study teams offshore and provided comments after database review, testing and defining edit checks specifications for assigned studies.

§Handled Phase I to Phase IV clinical trials data management activities that include study setup, conduct and closeout phases.

Acted as primary contact for all data management solutions, issues and questions from study teams and responsible for issue resolutions and have coordinated with offshore Data Managers/Team Leads/Data Management Project Lead.

Business Analyst :

Review and approve URS documents, UAT check list

Maintaining all the report documents, filing them in appropriate location.

Meeting with clients and programmer

Assign Reports to programmer

Publish the Reports in Prod Environment.

·Discrepancy Management

·Review and validation of programmed listings.

·3rd Party external vendor data reconciliation and management

·CRF Tracking, DCF creation, updates, and Query Management

·Manual and Auto Identification and resolution of data discrepancies

·Reconciliations (SAE, PK, BioMarker, IVRS, LAB, ePRO etc.)

·Individually handled CPPC’s for many studies.

Part of all major milestones (including paper CRF study, EDC study and transition of ongoing conduct study) and achieved them on or before time.

Quality Review.

·Interim and Final database transfer

·QC data listings/Data.

·Freezing and locking activities

• Promoting Business for kotak life insurance co Ltd, Recruiting and Handling Agency Managers, Team Leaders, Agents
• Conduct weekly meetings and Training for development of team members
• Address customer and employee satisfaction issue promptly
• Maintaining Good relationship with Agency Managers, Team Leaders, Agents and motivating to promoting the business and creating convention and contest qualifiers in the same
• Following up the logged in cases for Conversion on time

Ø Includes CRF Review, Discrepancy Management in different platforms such as Oracle Clinical and Inform

Ø Responsible for Clinical data Validation, Query generation and Integration.

Ø Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.

Ø Generate data queries to resolve data discrepancies.

Ø DCF Update including coding prior to database lock

Ø Identify and accurately resolve all workflow or clinical data discrepant issues.

Ø SAE reconciliation with the Oracle database and the clinical database

Ø Timely input for CRF designing and Data management plan

Ø Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures.

Ø Generate listings and perform data accuracy review

Ø Study overview presentation and Protocol Presentation

Ø Generate, review for accuracy and distribute status reports as requested.

Ø Perform quality review for new resources, Organize teleconference and team meetings, and Project documentation for Audits.

Effectively mentor less experienced staff. This may include assisting and guiding new personnel during their initial training period

KEY RESPONSIBILITIES

Identification of data discrepancies via computerized edit checks and manual data checks.

Review, update and correct data in the clinical database based on resolved data queries.

Perform additional data reviews activities to provide high quality data. Update tracking systems as necessary. Creation and maintenance of study files and other study documents.

Playing key role in process evaluation and redesign of data validation and UAT. Manage projects working with global teams. Trained and mentored junior data management staff on UAT, Client Specific application/tool, QC and Data validation.

MAJOR ROLES

Preparing Visit matrix

Giving inputs to SSU team and CRF designers§User Acceptance testing

Preparing Data Check Specification

Preparing Data Standard Documents

Preparing Data Management Plan and Data Entry Instructions

Data Validation

DQF Updating

QC

Maintaining Trackers