Mamatha J. Email and Phone Number
• A Clinical Data Management Professional experienced in Study Start-Up, Study Conduct and Database finalization activities along with Data Analysis.• Involved in clinical trial phases II, III of development exploring safety and efficacy to the final phase of clinical Development.• Working knowledge on EDC databases like Medidata Rave, Inform etc. as well as IXRS integration.• Taking lead at the project level meetings in providing the statuses, upcoming deliverables, and timelines.• In depth knowledge in Drug development process, clinical trial processes, data management, regulations (e.g., ICH-GCP, 21 CFR 11) and Quality Management.• Well versed with CDISC guidelines SDTM and CDASH standards.• Experience in development and review of Data Management Plans, Case Report Forms, Edit Check Specifications, database QC audits, external Vendor Data Reconciliation, and all other data management activities.• Ability to maintain quality data, privacy, and safety of the patients.• In depth knowledge of clinical study protocol and various clinical studies related document design.• Made sure all steps to a Quality Database release are met in accordance with the Clinical and Data Management timelines.• Involved in kick-off meetings and client meetings to oversee and update the project status.• Conduct data quality review meetings during the study execution.• Adherence on internal and external standards including SOPs, guidance document, and policies throughout the application process.• Experience in Vendor Management, Team management, Client Interaction and communicating with different departments within the clinical research domain.• Experienced in developing Data Transfer Agreement with external data vendors and/or core labs.• Serve as project database manager and work with vendors to obtain deliverables in a timely manner.• Collaborate with Biostatisticians regarding data validation and lock of the database.• Managed and mentored junior DM staff for providing clean datasets for analysis and demonstrated timely completion of all projects assigned with quality and handled multiple projects in parallel.• Well versed with Data Engineering skills.
Indiana University Bloomington
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- wuxiapptec.com
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- 3593
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Senior Clinical Data ManagerIndiana University BloomingtonDurham, Nc, Us
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Clinical Data/Automation ManagerWuxi Apptec Jul 2023 - PresentUnited States -
Senior Clinical Data ManagerIndiana University Bloomington Apr 2018 - Nov 2024United States• Manage end-to-end delivery of data management services for single/multi-service projects with minimal guidance, ensuring quality deliverables on time and within budget, to client satisfaction.• Develop and maintain the Data Management Plan throughout the life cycle of the study project and make sure the DMP is followed according to study plan.• Responsible for developing clinical Database specifications including eCRF design, user requirements, edit checks and data validations.• Actively involved in development of Test cases, Test plans and performed UAT for new study database.• Interact with members of other functional teams (Clinical Operations, Safety Surveillance, Biostatistics, Regulatory Affairs), Vendors (Clinical & CROs, Labs) regarding study-related issues.• Handle data transfers from external vendors (e.g., PK, ECG).• Document all activities of the study adequately.• Development and review of study documents like eCRF completion Guideline, External data reconciliation guideline etc.• Actively Involved in SAE reconciliation.• Profound knowledge working with IRT and ePRO.• Knowledge in Medical coding with MedDRA and WHO Drug.• Performed Automatic/Manual discrepancy management.• Data review through auto queries and listings.• Coordinate the archiving of study databases and related documents, including maintenance of TMF (Trial Master File) containing the documentation of entire trial team.• Profound knowledge and commitment in adherence to FDA, ICH-GCP, and IRB regulations.• Create Study metrics to monitor study progress to ensure the expectations are met as per the timeliness and quality.• Mentoring new joiners and providing training on organization specific Data management workflow.• Performed soft lock and prepared the database for statistical review, interim quality review and final database lock.
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Lead Data EngineerIndiana University Bloomington Oct 2016 - Apr 2018United States• Expertise in data warehousing, and data modeling.• Develop and maintain the project documents.• Manage the sprint planning process regarding the timelines and deliverables.• Implement efficient data pipelines (ETLs) to integrate data from a variety of sources.• SSIS package development, deployment, and maintenance for enterprise database systems.• Fine tuning execution plans for performance improvement, Error Handling, and Logging.• Experience in developing and maintaining automated CI/CD pipelines in Azure DevOps.• Expert knowledge of Data Management, Business Intelligence and Analytics concepts.• Analysis, architecture, design, and development of ETL, data warehouse and business intelligence systems.• Data Virtualization using DENODO: Creation, deployment and maintenance of base views, selection views, and interface views.• Creation of Cache Refresh Scheduler jobs to populate the data in DENODO views.• Creation of Web Servers to access the data from DENODO views from web applications.• Develop and maintain Power BI Deployment Pipelines.• Generate ad hoc reports for higher management for strategic planning as well as analytical dashboards that depicts critical KPIsusing both Power BI and Tableau.
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Clinical Data ManagerInfosys Jun 2012 - Jul 2015Hyderabad, Telangana, India• Review of study documents like eCRF completion Guideline, DMP, External data reconciliation guideline etc.• Responsible for developing clinical Database specifications, including eCRF design, user requirements, edit checks, query logic and data validations. • Serve as the role of back up for lead in managing the day-to-day CDM operations and client meetings.• Participate in client meetings, as necessary.• Handle data transfers from external vendors (ex: PK, ECG).• Perform/review SAE reconciliation and external vendor data reconciliation.• Performed discrepancy management (both automatic and manual).• Actively involved in development of Test cases, Test plans and performed UAT for new study database. • Create Study metrics to monitor study progress to ensure the expectations are met as per the timeliness and quality. • Provide inputs for improving the operational process and workflow, while maintaining the quality outcomes.• Freeze and lock the data on time for preparing the database for statistical review, interim quality review and final database lock.• key team member during study start-up process by performing user acceptance testing (UAT) of the database validation procedure, testing and providing feedback to the clinical database programmers. • As a part of UAT/ System Testing was Involved in testing various Edit Checks.• Review data through listings and auto queries, identify the discrepancies, issue queries, track, and follow-up query replies.• Reviewing and validating data in accordance with the Data Validation plan and Data Management Plan to ensure database consistencyand accuracy.• Escalation of identified unresolved issues to lead data manager on time.• Update all relevant tracking system on an ongoing basis. • Ensure compliance to Data management guidelines and departmental SOP's.
Frequently Asked Questions about Mamatha J.
What company does Mamatha J. work for?
Mamatha J. works for Indiana University Bloomington
What is Mamatha J.'s role at the current company?
Mamatha J.'s current role is Senior Clinical Data Manager.
Who are Mamatha J.'s colleagues?
Mamatha J.'s colleagues are Manxi Xiong, Dennis Dracup, Wendy Mao, Ling Wu, Lucas Hernandez, Joshua Pasmowitz, Jim Skeries.
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