Sravanthi Reddy Emmadi

Experience

• 

  Osmania General Hospital (OGH)

  May 2012 - Dec 2013

  Clinical Data Coordinator

   Initiating study start up activities. Co-coordinating for all client and internal meetings. Organizing study specific meetings.  Preparation of non eCRF guidelines and other documents for the project. Coordinating with all the internal team members of various departments for designing the eCRF and preparation of edit Specs. Initiating all the activities for the project to Go Live. Co-coordinating with vendors for the deliverables on time. Independently and accurately review Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures.  Perform Quality Reviews and appropriately address all issues.  Compile and distribute necessary study documentation and maintain accurate and complete study files in accordance with all applicable procedures.  Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings. Accurately perform Serious Adverse Event reconciliation in accordance with all applicable procedures. Accurately perform external data reconciliation in accordance with all applicable procedures.  Generate, review for accuracy and distribute status reports as requested. Show less

• 

  Accenture

  Jan 2014 - May 2020

   As a Sr. Clinical data manager, I have handled multiple studies with at least 3-4 team members like Data Associates and Interns Primary Data Management point of contact for all assigned DM tasks for the study. Oversee and coordinate tasks delegated to the study team members according to the budget provided. Activities that involve are managing projects and team, meeting timelines/deliverables with Quality, writing eCRF completion guidelines, writing test plan for Data validation specifications and testing. Query management, Vendor management, SAE management, QC, primary contact for programmers, vendors and Clinical team, handling Data transfers, Datasets review Managed delivery of projects through full data management study life-cycle  Managed project timelines and quality;  Performed comprehensive data management tasks including data review, writing and resolving data clarifications.  Performed comprehensive quality control procedures.  Independently bring project solutions to the CDM team.  Solved issues through using the global issue escalation/communication plan.  Understand and complied with core operating procedures and working instructions.  Developed and maintained good communications and working relationships with CDM team.  Interacted with CDM team members to negotiate timelines and responsibilities.  Trained team members Identified and reported protocol deviations Conducted reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action If required liaised with 3rd party vendors to clean electronic data Kept Manager informed about work progress and any issues to avoid surprises. Performed UAT, writing test cases and executing them Show less  Oversee and coordinated tasks delegated to the study team members according to the budget provided. Activities involved managing projects and team, meeting timelines/deliverables with Quality, writing eCRF completion guidelines, writing test plan for Data validation specifications and testing. Query management, Vendor management, SAE management, QC, primary contact for programmers, vendors and Clinical team, handling Data transfers, Datasets review Managed delivery of projects through full data management study life-cycle  Managed project timelines and quality;  Performed comprehensive data management tasks including data review, writing and resolving data clarifications.  Performed comprehensive quality control procedures.  Independently brought project solutions to the CDM team.  Solved issues through using the global issue escalation/communication plan.  Understood and complied with core operating procedures and working instructions.  Developed and maintained good communications and working relationships with CDM team.  Interacted with CDM team members to negotiate timelines and responsibilities.  Trained team members Identified and reported protocol deviations Conducted reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action If required liaised with 3rd party vendors to clean electronic data Ensured to update the Manager about work progress and any issues to avoid surprises. Performed UAT, writing test cases and executing them Show less

  • Senior Clinical Data Manager

    Jul 2015 - May 2020

  • Clinical Data Manager

    Jan 2014 - Jun 2015
• 

  Johnson & Johnson

  Jun 2020 - Aug 2022

  Lead Clinical Data Manager

   Primary Data Management point of contact for day to day activity on study. Lead and conduct all end-to-end CDM activities (Study build, Conduct & Lock) for assigned clinical studies Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry and reporting of clinical data.  Develops test scripts and execution logs for User Acceptance Testing (UAT) and performed UAT on forms and edits for new studies in the Development phase. Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.  Performed all aspects of data management tasks for multiple studies including data query, query resolutions, database updates, data base audits and data transfers. Participated in study data review including identification, resolution and clarification of any missing, inconsistent or clinically questionable data. Ensured high quality data for timely clinical trial analysis and reporting; plans, coordinates, and executes strategies to optimize database performance. Builds study databases, creating edit check logics and data validations. Oversees query management in collaboration with clinical operations personnel Create, review, and/or execute Form and Edit Check Specification User Acceptance Testing by creating/reviewing dummy data to evaluate EDC database functionality Show less

• 

  IQVIA

  Sept 2022 - Feb 2024

  Data Team Lead

  • • Worked as a Subject matter expert (SME) for Medrio database and helped the teams to resolve issues.• Successfully initiated and managed the study start up’s and achieved the milestone of Go-Live as agreed by Clients for multiple studies with very close timelines. • Successfully managed the study conduct and locked multiple studies in different databases as per Client’s expectation not limited to Phase 1, Phase III, pre clinical studies and Medical devices.• Performed User accepted testing (UAT) for Go- Live and all mid study updates. Data validation and eCRF development and edit checks development has been part of the role.• Provided leadership to the team in the areas of project planning, execution, and close-out, financial management, communications and milestone deliverables.• Conducted periodic data reviews and performed cleaning including reconciliation of data. Ensuring smooth conduct of study by running reports.• Provided Data management expertise to project management team, budgets, Clinical Operations, Biostatistics, external vendors and DM team members to manage continuous process improvements, issue escalation, workload projections, and provided technical expertise.• Lead all the internal data management meetings for assigned studies including internal review meeting, Kick off meeting and Online Screen Review meeting.• Ensured open communications with Client and IQVIA management to manage and meet contractual obligations.• Established strong communications with Data Operations team, functional leads, project managers and all Technical designing team.• Served as the escalation point for unresolved data issues in coordination with Biostatistics team.• Created and conducted a detail oriented review and ensured sign-off on all data management plan (DMP) documents.• With guidance, participated in and supported bid defense and Client expectation meetings (CEM).• Pioneered the lessons learned sessions after every milestone. Show less