Sita Turaga

• Supervise and oversee Data Management service providers (e.g., EDC vendor) to ensure adherence to predefined standards of quality and timeliness in deliverables,
• Act as core member of study team and provide CRO for end-to-end Data Management activities, manage data currency throughout the trial, and overall monitoring DM deliverables according to Service Level Agreement (SLA)
• Responsible for end-to-end clinical data management activities and serve as primary point of contact for internal and external study team members
• Authors, reviews/revises DM-related study plans including Data Quality Management Plan, Data Validation Plans, Data Review Plan, eCRF Completion Guidelines, and other study documents to ensure quality and standardization
• Perform Sponsor UAT by entering Dummy data (Screen UAT, Edit checks UAT)
• Chair Data Review meetings with cross-functional study team members and CRO to ensure ongoing review of trial data currency, quality, and completeness
• Be subject matter expert in clinical data management, demonstrating proficiency in industry best practices and offering insights to clinical team
• Lead and/or contribute to data management study initiation activities, encompassing formulation and evaluation of eCRF requirements, EDC database specifications, eCRF Completion Guidelines, Data Management Plans, Data Validation Specifications, and User Acceptance Testing
• Manage establishment and upkeep of data transfer agreements with external data vendors and oversee external data reconciliations
• Ensure that data captured in clinical database and by external vendors align with study objectives and quality benchmark
• Organized ongoing clinical data review and cleansing processes, identifying inconsistencies, omissions, or errors through meticulous data query procedures
• Maintain comprehensive internal data management files, ensuring preparedness for regulatory inspections
• Serve as representative of data management in cross-functional teams, delivering precise updates on study progress, timelines, and proactive communication regarding data management milestones, risks, and mitigation strategies.
• Coordinated with statistical programmers to ensure timely generation of analysis-ready datasets for clinical study reports.
• Worked effectively in fast-paced environments.

Study Setup Activities:

• Develop mock Case Report Forms (CRFs) and electronic CRF (eCRF) specifications for CRF builds, and contribute actively to all study documents, including Data Handling Plans (DHPs), Edit Check Specifications (ECSs), Clinical Coordination Guidelines (CCGs), and Data Transfer Specifications (DTSs)
• Collaborate with database programming team to design clinical database, conduct thorough testing of database using dummy data entry, and validate screens and edits
• Create comprehensive data transfer agreement and plan for vendor
• Work closely with database processors to validate Third-party data loads through test transfers

Study Conduct and Closeout Activities:

• Manage discrepancies effectively by initiating inquiries, responding to them, and closing queries once data has been rectified or verified
• Establish study status and metrics, actively participate in study meetings, and manually review datasets to ensure consistency, quality, and completeness of patient data
• Conduct comprehensive review of all Serious Adverse Event (SAE) Reconciliation activities and protocol deviations
• Oversee and monitor processes of database locking and freezing, ensuring their successful execution
• Provide project manager with pertinent research metrics, proactively identify potential risks, and efficiently manage available resources
• Engage in continuous data review, including reconciliation of third-party data streams and serious adverse events with safety database
• Implement quality control procedures, such as internal database reviews, visual checks on data transfers, and interim data reporting
• Possess extensive experience in therapeutic fields, including oncology, chronic kidney disease, respiratory illnesses, and antiviral studies
• Conduct vendor data reconciliation (ePRO, IVRS, lab, PK, imaging) and maintain communication with Sponsor
• Handle post-production change (PPC) activities, which involve identifying and addressing database issues, reviewing updated documents for migration, and testing database updates
• Examine Study Data Tabulation Model (SDTM) datasets and resolve any associated issues
• Conduct quality checks on work performed by peer data managers
• Ensure that all open queries are resolved before finalizing database.

• Created several status reports using J-review process, and reviewed data using listings and EDC system
• Helped manage and update study documentation like CRF Completion Guidelines, Data Management Plan, Study Design Requirements, and Data Validation Plan
• Reconciled research data with data from lab
• Assisted in review of test scripts, query logic, and edit checks for accuracy in user acceptance testing
• Manually reviewed study data to perform quality checks
• Created checklist that aids in quality assessment of Data Management operations before locking during study close-out
• Monitored development of data management tasks for assigned projects to make sure adherence to deadlines and specifications was met.
• After analyzing study procedure, created Case Report Forms (CRFs)
• Examined given procedures and changes and gave clinical team input
• Checked and amended reports as needed for data discrepancies
• Served as single point of contact for SAS teams, biostatisticians, and clinical data team.

• Responded to customer inquiries and provided technical assistance over phone and in person.
• Developed and implemented preventive maintenance procedures.
• Monitored system performance to identify potential issues.
• Researched and identified solutions to technical problems.
• Conversions: Knowledge on Session Method, Call Transaction Method and LSMW
• Enhancements: Knowledge of User Exits, Customer Exits and BADI's
• Forms: Knowledge on developing and modifying SAP Scripts and Smart forms
• Data Dictionary: Knowledge of creating Tables, Structures and Views
• Dialog Programming: Good Knowledge of Transaction/Screen development using Screen Painter - Table control Custom control and Tab Strips, Menu Painter

• Completed wide range of tasks in diverse filming areas to support operations.
• Stayed alert, active, and ready to respond to any request at any time using variety of available resources.
• Communicated with other crew members via walkie talkies to coordinated production activities.
• Supported current production needs by moving items between equipment, conveyors, and staging areas.
• Standard Operating procedures (SOPs) followed to ensure Quality Assurance.
• Update documentation on QA and other processes.