Summary
Overview
Work History
Education
Skills
Websites
Projects
Publications
Accomplishments
Timeline
Generic

Sai Prathyusha Vytla

Spring,United States

Summary

Clinical Data Manager with a proven exprience in Clinical data management, in EDC Systems like Medidata Rave, Inform and Veeva vault. Excelled in data reconciliation and analysis, enhancing data integrity and accuracy. Skilled in SQL, with a commitment to driving project success and innovation in clinical data management practices for clean data from study startup to study close-out. Active collaboration with cross-functional teammates to set modeling, quality, and specification compliance.

Overview

7
7
years of professional experience

Work History

Data Manager, Global Development

Regeneron
, United States
04.2023 - Current
  • Work on building edit check specifications for multiple therapeutic areas.
  • Work on building eCRF completion guidelines for multiple therapeutic areas.
  • Worked across multiple databases, like Medi-Data RAVE, and Inform.
  • Developed specifications while working with cross-functional teams for the data listing to perform data cleaning activities and data reconciliations.
  • Worked with the CRO (IQVIA) to build the edit check library, and to conduct testing and validation.
  • Developed data management plans, reports, validation procedures, and data entry processes.
  • Worked closely with the clinical and data management leads of the various therapeutic areas for compiling the global data management guidelines and documents.
  • Working with the programmers for the database built, user acceptance test validation for the edit checks, and the data listing specification developed for both study-specific and global library.
  • Working on change requests to accommodate the change in the standard form, but also according to CDASH CDISC standards.
  • Working with clinical data management deliverables generated by external vendors (e.g., CROs) for outsourced study activities, such as CRF design, database set-up activities, database specifications, data validation processes, user acceptance testing, training of study site personnel in CRF completion, and data clarification processes.
  • Proactively trained the new members about the team tasks, and supported and assisted in standard library validation and review for the review cycle.
  • Participate in cross-functional team meetings as requested, communicate with all departments regarding project statuses and issues, provide ongoing feedback on data management workflows to increase efficiency, and provide feedback.
  • Worked on report development using tools such as J-Review (SQL queries) for six studies for the oversight reports for the CDM study teams.
  • Worked with the clinical teams and stats teams to develop specifications for data listings.
  • Developed custom J-Review reports for data validation and data cleaning for six studies, especially in phases 2 and 3 of oncology and hematology studies.
  • Worked with cross-functional teams of all therapeutic areas for the standards e-CRF review, with the CDISC review.
  • Demonstrate your proficiency in using clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
  • Developing CDISC-compliant study data collection (eCRFs): I actively participated in the design and development of eCRFs to ensure they captured data elements according to CDISC and CDASH standards.
  • Worked on multiple studies for the clinical and oversight listings, and the development of standard listing specifications for multiple therapeutic areas and cross-functional standard forms.
  • Reviewed source documents and listings to compile resources.
  • Reviewed source documents and listings to compile resources for identifying and correcting data allocation issues.

Data Associate

Beaumont County Health Department
, United States
01.2023 - 05.2023
  • Worked with the county clinic for data entry, converting paper data to electronic.
  • Worked on developing a digital e-DOC testing
  • Done a study to analyze the STD's pre-COVID pandemic and post-COVID pandemic
  • Worked on training clinic staff using the e-DOC and data analysis.
  • I located and corrected data entry errors, and reported them to management.
  • Utilized established methods for data processing and analysis for consistency and accuracy.
  • Leveraged advanced Excel functions for data manipulation and analysis.
  • Applied data validation procedures to support and enforce data integrity.

Graduate Research Associate

Sam Houston State University, School of nursing with collaboration of Texas State Public Health Department
, United States
03.2022 - 05.2023
  • Assisted Dr. Devon Berry with his two studies: "Vaccine Hesitancy in Nursing Students of Texas," and "PTSD in Nursing Students."
  • My responsibilities included organizing and maintaining regulatory documents related to the research studies in the site binder to ensure accuracy and integrity.
  • I worked on building surveys for data collection, cleaning, and interpretation to analyze study results. Additionally, I contributed to data interpretation and utilized tools such as SPSS, Qualtrics, and SurveyMonkey for data collection and analysis.
  • As the primary point of contact for the external team involved in data collection, I handled survey design and development for both studies. I also engaged with clients for study enrollment and assisted in developing and reviewing key performance indicators (KPIs) and goals.
  • I effectively managed the workload determined by the Trial Manager, overseeing, analyzing, implementing, and verifying Data Clarification Forms (DCFs) submitted through the Trial Manager.
  • I assisted in applying and interpreting data to drive quality improvement efforts, and I addressed issues or questions from the client study team, physicians, and site staff.
  • I managed assigned project timelines, prioritized tasks, helped establish standard processes and procedures for the department, and actively trained new team members while performing knowledge transfer activities.

Associate Clinical Data Coordinator

IQVIA
Bengaluru, India
01.2020 - 08.2021
  • Worked across multiple databases, like Medi-Data RAVE and Inform (6.1 and 6.2).
  • Performed data cleaning activities by reviewing data listings, querying the database, and performing clean patient trackers.
  • I have experience in Excel data analytics methods for the data analysis of project status and clinical data.
  • Developed data management plans, reports, validation procedures, and data entry processes
  • Implemented clinical system requirements, including data release formats, delivery schedules, and testing protocols.
  • Worked on eCRF guidelines and specifications for the e-CRF design
  • Worked on e-CRF validation and custom report validations.
  • Worked on assigned studies to identify data issues, and proactively address data issues.
  • Ensure rapid identification of database errors, and proactively work with the database programmers to address.
  • Worked on vendor data reconciliations and SAE reconciliations between the clinical and safety databases.
  • Worked on multiple studies with safety data for SAE and AE reconciliations.
  • Collaborated with clinical and biostatistics teams to successfully lead and assist with data review, interim analysis, and final database locks for over three studies.
  • Proactively mentored team members for the activities like data validation plan but documenting data validation test cases for study UAT at study start up and during the study at the PPC for 9-10 studies during my term in IQVIA.
  • Assisted the team with the tasks during a PPC for the study and trained the new team members as team buddies for over 4-5 studies.
  • Worked closely with the CRA, worked on the site issues data flow issues
  • Worked on custom and standard reports of the databases
  • Created and worked on the validation of eCRF design and edit checks for their assigned studies, using the study-specific Data Management Plan and protocol for two studies.
  • Reviewed data listings for accuracy and consistency of data.
  • Identified, resolved, and updated on data discrepancies.
  • Overseen DM operation to ensure the quality and timely delivery of DM services through 2 studies.
  • Worked as DOC and supported DTL for two studies in different stages of a study life cycle.
  • Participated in quality assurance reviews to verify the accuracy and reliability of data.
  • Enforced data validation rules to maintain the accuracy and completeness of clinical data.
  • Created data management plans and provided input on study designs.
  • Collaborated with medical teams to create uniform standards for clinical data reporting.

Research And Development Associate

Cadilla Pharmaceuticals Limited
Ahmedabad, India
06.2018 - 12.2019
  • Worked on Microbial technology development for the Agro Product development
  • Have worked on multiple studies on the development and test of microbiology products for the Agro supplies
  • Worked on technology transfer and documentation of specification for the scaling up of production from lab Pilot to industrial production
  • Trained personnel on laboratory functions
  • Created technical and research documents such as environmental impact reports
  • Supervised biological technicians, technologists, and processes
  • Managed quality assurance program, including on-site evaluations, internal audits, and customer surveys
  • Participated in team-building activities to enhance working relationships
  • Proved successful working within tight deadlines and a fast-paced atmosphere
  • Worked closely with the HOD of Biofertilizer to maintain optimum levels of communication to effectively and efficiently complete projects

Intern

Biocon
Bengaluru, India
01.2018 - 06.2018
  • Entry, and maintaining and analysis for reporting
  • Kept up with the busy schedule of work and studies to maintain class standing and internship eligibility
  • Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies
  • Compiled and distributed weekly feedback to team leaders and managers to improve service quality while increasing productivity

Education

Master's in public health - Public health and social justice

Sam Houston State University
Huntsville, United States
05.2023

Bachelor of Engineering - Biotechnology

RV College of Engineering
Bengaluru, India

Skills

  • Data management
  • EDC Systems (Medidata Rave, Inform, Veeva Vault)
  • Data Management Software (Excel, SAS)
  • Data reconciliation
  • Data Analysis and Interpretation (SPSS, J-Review)
  • Data validation and Data cleaning
  • Cross-functional collaboration
  • e-CRF design
  • Edit check and data listing Specifications
  • Data Management Plan
  • Report development
  • Study start-up, PPC, and close-out activities
  • SQL proficiency

Websites

Projects

A Tool Development for comparing the inter and intra species variation and conservation in Pathogen for KIMS, CASE Study: Streptococcus pneumonia and Streptococcus mitts., 01/01/22 - 05/31/23 Covid-Vaccine hesitancy Study within Pre-licensure Nursing Student in Texas, The purpose of this study was to describe the level of vaccine hesitancy and hesitant adoption among nursing students in the state of Texas., 04/01/22 - 06/30/22 Stress and Trauma Among Nurses in Development (STAND), The purpose of this study is to understand the experience of trauma exposure and resulting symptoms in undergraduate nursing students., 01/01/22 - Present

Publications

Vaccine hesitancy and hesitant adoption among nursing students in Texas

Accomplishments

  • Vaccine hesitancy and hesitant adoption among nursing students in Texas

The purpose of this study was to describe the level of vaccine hesitancy and hesitant adoption among nursing students in the state of Texas.

We used a convenient, opt-in, online survey of nursing students conducted between mid-April and mid-June 2022.

Timeline

Data Manager, Global Development

Regeneron
04.2023 - Current

Data Associate

Beaumont County Health Department
01.2023 - 05.2023

Graduate Research Associate

Sam Houston State University, School of nursing with collaboration of Texas State Public Health Department
03.2022 - 05.2023

Associate Clinical Data Coordinator

IQVIA
01.2020 - 08.2021

Research And Development Associate

Cadilla Pharmaceuticals Limited
06.2018 - 12.2019

Intern

Biocon
01.2018 - 06.2018

Master's in public health - Public health and social justice

Sam Houston State University

Bachelor of Engineering - Biotechnology

RV College of Engineering

Similar Profiles

CREATE PROFILE
Sai Prathyusha Vytla