Bhagath Kumar Reddy Kaithi

Serve as primary point of contact for customer on data management activities

• Provide project management expertise working with customer data managers, key decision makers, and internal team members to manage continuous process improvements, issue escalation, workload projections, and provide technical expertise
• Provide justification for and perform direct negotiations with customer, e.g., timelines, financial, process, resources
• Maintain Data Management study files in audit ready condition
• Ensure open communications with customer and IQVIA management to manage and meet contractual obligations
• Worked extensively during study start up on clinical data base designing and CRF designing in accordance with CDISC/ SDTM/CDASH guidelines
• Meet with Data Operations Coordinator (DOC) and/or Data Operations team members on regular basis to ensure milestones meet timelines and quality deliverables
• Establish strong communications with Data Operations team, functional leads, project managers and all other stake holders
• Serve as escalation point for unresolved data issues; work with client data managers, vendors, internal team members for resolution
• Create and/or review and sign-off on all data management plan (DMP) documents
• Ensure service and quality meet agreed upon specifications per DMP and contract/SOW
• Serve as Subject Ma er Expert (SME) in Specialty lab reconciliation, Restricted data handling review, Post Production changes
• Provide leadership and expertise in specific CDM task or technology
• Train and mentor junior DTL staff in DM expertise
• Manage SOW/budget and allocate hours to Data reviewers and programming team
• Review financial reports on monthly basis and participate in project reviews as requested
• Serve as Project Manager for single service DM projects, including financial tracking, revenue recognition, and invoicing
• Lead and/or participate in focus team or global or local standard methodology team
• Communicate lessons learned and/or present in CDM workshop(s)
• Participate in development and implementation of new technology or tool
• Present at professional conferences and/or publish articles in professional journals
• Trained new team members by relaying information on company procedures and safety requirements.
• Enhanced overall team performance by providing regular coaching, feedback, and skill development opportunities.
• Collaborated with other department leads to streamline workflows, improve interdepartmental coordination, and achieve business goals collectively.
• Nurtured long-term partnerships with clients by understanding their needs accurately, delivering projects on time, and providing exceptional customer support.

• Performed SAE reconciliation worked closely with safety and external vendor data reconciliation
• Reviewed and approved Case Management Plans, Data entry completion guidelines and other key documentation
• Created and reviewed data clarification forms and updated database accordingly
• Performed QC of data by manual reviews
• Managed caseload of over clients, conducting comprehensive assessments and developing individualized care plans to address their needs
• Coordinated services and resources, including healthcare, housing, and social support, by collaborating with community organizations and government agencies
• Maintained accurate and up-to-date documentation of client progress, ensuring compliance with HIPAA regulations and agency policies
• Facilitated regular meetings with clients to monitor their progress, address challenges, and adjust care plans as needed
• Responded to crisis situations promptly, providing support and connecting clients with appropriate services
• Utilized Ontario health portal software to track case progress, manage tasks, and generate reports for management and funding purposes
• Proficient in conducting client assessments to identify needs and develop tailored care plans
• Strong ability to document case progress, maintain accurate records, and ensure compliance with regulatory requirements
• Demonstrated expertise in crisis intervention and conflict resolution address client emergencies and challenges.
• Supported case management team by providing backup coverage and assistance during periods of high caseloads or staff shortages.
• Maintained accurate records by diligently updating case files and documenting client interactions in timely manner.
• Advocated for clients'' needs within healthcare system, working closely with providers to ensure appropriate care was provided promptly and efficiently.
• Managed caseloads effectively, ensuring timely updates and documentation of all case activities.
• Ensured compliance with regulatory standards and requirements by conducting audits and maintaining up-to-date knowledge of industry guidelines.

Clinical data coordinator on phase II -III randomized Oncology and Hematology studies performing clinical data management activities

• Acts as liaison between study teams and third-party data management CROs
• Reviewed and approved Data Management Plans, CRF completion guidelines and other key study documentation
• Performed QC of data by manual reviews.
• Participated in study startup process by performing User Acceptance Testing of database
• Validation procedure testing and provided feedback to clinical data programmers and Data Managers
• Worked on Lab reconciliation including local and central labs
• Performed SAE reconciliation worked closely with safety and external vendors
• Developed and executed queries in clinical databases
• Performed discrepancy managements (both manual and automated)
• Responsible for coding all AEs to MedDRA and Cons Meds to WHO Drug dictionary
• Data locking and freezing ac vi es as appropriate in me for statistical review blinded interim quality review, interim and final database lock
• Performed internal audits to maintain integrity of clinical trial results
• Maintained documentation of data management activities
• Archives all data management study documentation per agreement with clients
• Generated summary reports based on data collected from clinical trials
• Worked closely with all stakeholders in study like monitors, database programming, medical coding and statistical programming teams to ensure proper functioning of studies.
• Supported statistical analysis efforts by providing clean, accurate, and complete datasets for interpretation.
• Improved overall clinical trial outcomes by maintaining strict adherence to established timelines and milestones throughout all stages of process.
• Enhanced data accuracy by implementing thorough quality control processes in clinical data management.
• Worked with programming to coordinate Study Data Tabulation Model maps.