Prathyusha Thota
Summary
Six years of experience in CRO, specializing in clinical data management and investigator payments. Proven expertise in project management, phase II and phase III clinical trials, and site management using systems like Impact Harmony and Oracle. Strong skills in stakeholder management, data analysis, and ensuring timely and accurate payments
Overview
6
6
years of professional experience
6
6
years of post-secondary education
Work History
Senior Data Alignment Analyst
IQVIA
7 2022 - Current
- Ensured fulfillment of contract specifications and ad-hoc client requests to build client satisfaction, under supervision
- Assisted team members in building, establishing, and maintaining effective business relationships with clients to proactively support their needs as their day-to-day contact
- Delivered accurate and on-time site payment data for all IQVIA studies
- Interpreted and understood EDC subject visit data, site contracts, and the payment system design and payment triggers
- Analyzed data fallout and provided necessary corrections to ensure sites were paid accurately
- Identified data flow issues on large, complex, and ongoing studies; routed these to the appropriate teams for action and saw the issues through to resolution
- Managed stakeholders involved in the process, including the coordination of accurate payment reconciliations
- Project managed team members from five different internal IQVIA groups, understanding their processes and how to effect change
- Directly resolved EDC, Data Warehouse, and CTMS payment system issues that were preventing payments
- Ensured, through review and verification, that the product deliverable met the customer’s specifications, including timeliness and quality
- Worked on EDC portal, CTMS, Insite, and Drug Dev
- Monitored performance against existing service agreements and ensured client obligations were met
- Researched, analyzed, and responded to client inquiries requiring an in-depth understanding of the client, specific business line, and/or therapeutic market
- Delivered accurate and on-time site payment data for all assigned change control studies
- Conducted visit comparisons for EDC to SDH or using PSAT application along with SVT alignment comparison
- Built project reports as requested from sponsors, operations, accounting, and upper management to support the monthly close process
- Performed quarterly ad-hoc gap analysis to get an overview of the investigator fee budget
- Managed project stakeholders involved in the process, including the coordination of accurate payment reconciliations
- Directly resolved EDC, Data Warehouse, CTMS, or Drug-Dev payment system issues that were preventing payments
- Ensured, through thorough review and verification, that the product deliverable met the customer’s specifications, including timeliness and quality
- Monitored performance against existing service agreements and ensured client obligations were met
- Evaluated CTA and set up budget funds in Insite for payments
- Verified invoices and audited high-value payments
- Examined and interrogated clinical trials
- Worked on change control studies for manual tracking in CTMS, ultimately ensuring smooth payments to sites
- Investigated discrepancies and communicated with vendors to ensure the completeness of transactions.
Investigator Payments Specialist
PAREXEL International
01.2019 - 01.2022
- Worked independently and reliably, showing a high level of ownership, with a strong focus on the collection, validation, and analysis of project-related data and operational information from various sources, including contracts related to investigators
- Managed end-to-end investigator payment processing, schedules, and timelines
- Thoroughly understood protocols and reviewed them during contract preparation to mitigate future budgeting and payment errors
- Contacted and followed up with study teams or sites for reconciling clinical data along with CSAs and protocols
- Hosted seminars and meetings to update sites and clinical teams on process changes
- Conducted study calls with Clinical Operation Leaders (COLs), Project Leaders (PLs), and Project Specialists (PSs) to amend contracts as required
- Processed payments for patient visits and passthrough costs, considering all clauses and amendments in the contracts using company proprietary tools
- Handled patient drug intake and dosage data to track study outcomes
- Processed patient data in Excel as per client requirements
- Assisted in budget preparation intermittently
- Worked on CTMS-IMPACT HARMONY for data cleanup and scrutiny
- Assisted project teams in project planning and timely payments to investigators
- Accompanied management to audits and assisted lead auditors when required
- Assisted with study data quality checking and query resolution
- Contacted site personnel for details regarding patient recruitment, coordinated patient visits, and made oversight payments to investigators, following up until remittance advice was sent
- Maintained proper contract files, amendments, and notifications
- Analyzed business intelligence reports and communicated with project-related teams
- Coordinated with vendors for setting up new requirements and change requests
- Adhered to timelines set by the research team for various activities
- Ensured research activities met set quality standards
- Performed reconciliation on investigator payments.
Education
Certification in CDM & PV -
IDDCR Institute
01.2018 - 12.2018
Bachelor of Pharmacy - undefined
Srinivasa Institute of Pharmaceutical Science
01.2013 - 12.2017
Skills
Good Clinical Practices
Interpersonal and Management Skills
Verbal and Written Communication
Organizational Skills
MS Excel
MS Word
MS PowerPoint
Data Analysis
Stakeholder Management
Project Management
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge.
Timeline
Investigator Payments Specialist
PAREXEL International
01.2019 - 01.2022
Certification in CDM & PV -
IDDCR Institute
01.2018 - 12.2018
Bachelor of Pharmacy - undefined
Srinivasa Institute of Pharmaceutical Science
01.2013 - 12.2017
Senior Data Alignment Analyst
IQVIA
7 2022 - Current
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