SOWMYA SRI AVIRNENI
Saint Charles,MO
Summary
With a proven track record at ACCENTURE, I excel in clinical data management and team building, ensuring top-notch data quality and effective team leadership. Recognized for outstanding contributions with the Way of Working and Star of Business awards, I bring expertise in CDISC standards and a knack for fostering significant team development. Highly skilled Senior Clinical Data Manager with a solid background in clinical research and data management. Proven ability to manage large databases, ensure data integrity, maintain compliance with regulations, and interact effectively with cross-functional teams. Strengths include strong analytical skills, problem-solving capabilities, leadership qualities and proficiency in various data management software. Consistently deliver high-quality work that contributes to improved efficiency and accuracy of clinical trials.
Overview
4
4
years of professional experience
1
1
Certification
Work History
Senior Clinical Data Manager
ACCENTURE
Hyderabad, India
08.2021 - 03.2024
- Oversaw project-level DM tasks ensuring consistent approach and timely database delivery
- Conducted quality control checks to ensure delivery of quality databases
- Developed and coordinated training for DM staff, ensuring consistent and comprehensive training
- Managed vendor relationships and led vendor results at the project level
- Communicated project-level issues related to processes, timelines, resourcing, and performance
- Led electronic submission activities and assisted with audit responses from Clinical Quality Assurance
- Review and resolve/action discrepancies identified by the system or through manual checks as per guidelines
- As required, review data using reports from tools like J Review, Electronic Data Management(eDM), Rave, CDW, Trail access Online, SQL Developer, Study Management tool, etc
- To identify and resolve quality issues
- Generating and reviewing Case report form summary report and track missing pages, as required for the data type
- Reviewing all data present on laboratory case report form pages as well as reference information that supports these data as applicable
- Experience in External data activities with vendors like CRO's, central labs, imaging vendors
- Perform Manual review and add queries on to data base based on frequency mentioned in Appendix 2B (Both Lock and Non- Lock) studies
- If required Confirm documents are available in eTMF as per the study specific TMF List and Milestone management zone
- We used to perform content review of documents classified under data management zone in eTMF in accordance with the data management checklist
- Ensuring 100% compliance on Accenture and client trainings including study or protocol trainings prior to working on the study
- Track discrepancy and query status of assigned investigative sites/clinical via /eDM Reports for RAVE Studies, as applicable
- Performed QC Checks for both Internal and external Studies for all the Therapeutic Areas
- Act as a coach to team members by helping them in developing and maintaining various skill sets, abilities and competencies, along with KT Sessions and Mentoring
- I received the Way of Working award and Star of Business awards during my business period which motivated me to improve team building
Application Intern
Davis Laboratories Ltd vishakapattanam
Chippada, India
04.2020 - 06.2021
- Analytically skilled in Clinical Data Base of Collecting, integrating, management of Clinical Trials for development of safety, quality of the drug
- By using different tools and working on site payment activities in Clinical trials
- Experienced in Study Startup, Study Conduct and study closeout phases of Clinical data management
- I have hands on -experience in various therapeutic areas like Oncology (CA), Immunology (IM), cardiovascular (CV), and even handling Newco studies
- Having experience in UAT (User acceptance testing) with Different Roles
- Worked closely with systems analysts, programmers to understand limitations, develop capabilities and resolve software problems.
Education
Bachelor in Pharmacy - Pharma
JNTU Kakinada University
Kakinada, India07.2021
Skills
- CDISC standards
- Clinical data management
- Data quality control
- Data reporting
- Database development
- Data reconciliation
- Clinical research coordination
- Listing review
- External data review
- CDISC Standards
- Communication
- Industry standards
- SAE Reconciliation
- Researching
- Team building
- Public speaking
- ICH-gCP guidelines
- Clinical data interpretation
- Data validation techniques
- Medical coding
- Data security
- Data query management
- Data cleaning
- Adverse event reporting
- Data governance
- Medidata rave
- Electronic data capture
- Data standardization
- Data entry supervision
- Data migration
- Protocol development
- Biostatistics
- Site management
- Clinical trial design
- Data mapping
- FDA regulations
Projects
Vendor Management, Led vendor results and maintained strong vendor relationships at the project level. Respiratory Disease Study, Managed vendor relationships, ensuring timely delivery of data and resolving any issues efficiently. Assisted with responses to questions and findings from Clinical Quality Assurance and other audits. Cardiovascular Outcomes Study, Led the coordination of DM tasks, ensuring timely and accurate database delivery. Conducted quality control checks to ensure high-quality databases, addressing any discrepancies promptly. Quality Assurance, Conducted regular quality control checks to ensure high-quality databases. Diabetes Treatment Study, Led electronic submission activities, ensuring adherence to submission requirements. Developed comprehensive quality control protocols to maintain data accuracy and reliability. Communication and Documentation, Communicated project-level issues, including processes, timelines, resourcing, and performance. Infectious Disease Study, Ensured effective communication across all project teams, facilitating smooth project execution. Reviewed all study-level non-DM documents for project-level consistency and awareness. Participated in the development, review, and implementation of DM processes, policies, SOPs, and associated documents.
Technical Skills
RAVE EDC, RAVE X, SAS, CDW, J-REVIEW (12.0), VEEVA VAULT, Query resolution, Query Management, listing review, External data review, CDISC Standards, Communication, Industry standards, SAE Reconciliation, Researching, Team building, public speaking
Affiliations
- problem solving
- adaptability
- learning new skills
Accomplishments
- Received Way of working award & start of Business award in Accenture.
- Got 2nd prize in BITS Pilani Hyderabad for presentation skills.
Certification
- Certified in RAVE, Clinical data management, Pharmacovigilance & SAS.
- Certified in GCP
Languages
English
Professional
References
References available upon request.
Timeline
Senior Clinical Data Manager
ACCENTURE
08.2021 - 03.2024
Application Intern
Davis Laboratories Ltd vishakapattanam
04.2020 - 06.2021
Bachelor in Pharmacy - Pharma
JNTU Kakinada University
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