Rajeswari Jagarlamudi
Boston,MA
Summary
- Highly experienced clinical data management professional with 6+ years of professional experience in successfully managing clinical trials and studies from phase I to III, extensive hands-on in study start-up, study conduct, and database lock.
- Profound working knowledge of multiple EDC databases, including Medidata Rave, Oracle Inform, Veeva Vault, IBM Clinical, and Medrio and Safety databases like Argus and Aris.
- Worked on different therapeutic areas like Oncology, Neurology, Rare diseases, Respiratory diseases, Liver diseases, Hematology, Ophthalmology, etc.
- Competent in CDISC/CDASH, SDTM, AdaM, 21 CFR PART 11, ICH, GCP, GCDMP, and US FDA safety reporting and recommendations.
- Excellent attention to detail, ability to interpret protocol, and provided inputs from DM perspective to all other internal stakeholders for collection of data.
- Created eCRF specifications and maintained databases, ensuring data accuracy and completeness.
- Experienced in performing Data Validation (edit check) Specifications, electronic Case Report Form Completion Guidelines (eCCGs) and Data Management Plan (DMP) throughout the project life cycle.
- Database development expertise, including User Acceptance Testing (UAT), Query logic, and Edit Checks.
- Coordinated and tested live database tasks (Go-Live) for studies once the study start-up activities were finalized.
- Performed quality review of data transfers, e1nsuring the external data is of high quality and follows the structure and format of the DTA/DTS to ensure successful execution of clinical trials.
- Reviewed external data reconciliations like IRT reconciliation, Lab reconciliations (both local and central), PK/PD reconciliation, SAE reconciliations, etc.
- Responsible for performing Discrepancy management, raising Data Clarification forms, updating the communications logs and trackers.
- Performed Data Review activities using Data Review Plan, SAS listings, and data visualization tools like Spotfire and Elluminate. Resolved issues identified during the data review process and worked with either sites or vendors as needed.
- Carried out quality checks/QC, data freezing, and locking of DB (Interim Analysis/Snapshots/Soft locks) and final database hard locks.
- Responsible for developing and implementing the SDV plan to ensure the targeted SDV is completed according to the protocol and regulatory requirements.
- Capable of leading cross-functional teams and working with various stakeholders to ensure that timelines are met.
- Ensured ongoing documentation was maintained, TMF filings were accurate, and decision logs were up to date.
- Involved in internal/Sponsor, external vendor, and investigator meetings for project updates and solutions.
Overview
7
7
years of professional experience
Work History
Lead Clinical Data Manager
Fulcrum Therapeutics
05.2022 - Current
- Involved in study build, including eCRF design review, kick-off meetings, Protocol review, edit checks, DMP review, and modification, ensuring that all updates are captured accordingly
- Reviewed protocol, case report forms, informed consent forms, study operations manuals etc
- Designed annotated eCRFs in accordance with the CDISC/CDASH guidelines and the study protocol
- Performed database design as required by the study protocol and developed and reviewed the eCRFs in compliance with the protocol and the eCRF Completion guidelines
- Composed and amended edit checks specifications for EDC during study start-up
- Evaluated and examined visit structure functionality, comprehensiveness of the screens, and edit checks by performing User Acceptance Testing
- Reviewed study documents like Data Management Plan (DMP), eCRF completion guidelines (eCCGs), external data reconciliation guidelines, and departmental SOPs
- Prepared Data Transfer Agreements (DTA) between the company and several external vendors based on the guidelines
- Reviewed external data transfers from vendors, like IRT reconciliation, Lab reconciliations, Pharmacokinetic and dynamic reconciliation, and SAE reconciliations, raised0 queries, and resolved data quality issues
- Expertise in data cleaning activities, including processing queries, ongoing data review, data trends, and Query management to ensure quality standards are achieved for successful database lock
- Employed the Data Review Plan (DRP); queries were created and carried out in EDC as part of the data review process
- Data listings were built for monthly data review
- Identified discrepancies and issued queries, kept track of query status, and developed query responses
- Implemented usage of data visualization tools like Elluminate for data review
- Ensured FDA regulatory standards compliance (particularly 21 CFR part 11), performing quality assurance on electronic data capture tools
- Successfully handled the allocated projects in line with deadlines and deliverables
- Coordinated with the cross-functional clinical team, including Biostatisticians, Medical Monitors, Clinical Operations, DB programmers, and regulatory professionals, to develop DM and study-related documentation
- Generated customized data reports by using J review
- Ensured data accuracy at different time points and validated clean reporting
- Carried out the pre-lock checklist tasks to ensure all the data had been examined and produced accurate data for database locking
- Carried out quality checks/QC, data freezing, and locking of DB (Interim Analysis/Snapshots/Soft locks) and final database hard locks
- Responsible for developing and implementing the SDV plan to ensure the targeted SDV is completed according to the protocol and regulatory requirements
- Participated in client interaction meetings and external vendor management
- Ensure adherence to the basic protocol requirements, SOPs, ICH, GCP, and Standard Guidelines.
Clinical Data Manager
PPD
09.2021 - 04.2022
- Involved in study build, including eCRF design, kick-off meetings, Protocol review, edit checks, DMP review, and modification, ensuring that all updates are captured accordingly
- Responsible for data management activities across multiple studies from study start-up through study closure to ensure completion per established project team goals and objectives
- Developed and managed project timelines and monitored study progress against established timelines and milestones
- Maintained regular communication with team members, vendors, and study sponsors regarding study status and progress updates
- Ensured that project team communicates and follows clinical trial protocol and had a shared understanding of how data will be captured and cleaned in the process
- Reviewed and evaluated written data eCRFs design based on CDASH and CDISC standards
- Participated in EDC development, including eCRF development, EDC specification process, and sponsor User Acceptance Testing, including test scripts and execution logs, validation documents such as edit check documents, issue logs, UAT summary reports, etc
- Evaluated and examined visit structure functionality, comprehensiveness of screens, and edit checks by performing User Acceptance Testing
- Worked closely with cross-functional study teams, including clinical operations, medical affairs, biostatistics, and regulatory affairs, to ensure that clinical data are complete, high quality, and delivered on time and budget
- Effectively oversee contracted vendors or vendor groups within CRO to ensure data are complete, accurate, and delivered within agreed timelines
- Actively participates in team meetings and presents Data Management concerns, risks, and issues
- Followed guidelines of Data Transfer Agreement (DTA) between clients and CROs in line with GCPs; developed Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs
- Reviewed external data reconciliations like IRT reconciliation, Lab reconciliations (both local and central), PK/PD reconciliation, SAE reconciliations, etc
- Performed data review activities using Data Review Plan and SAS listings
- Resolved issues identified during data review process and worked with either sites or vendors
- Expertise in data cleaning activities, including processing queries, ongoing data review, data trends, and Query management to ensure quality standards are achieved for successful database lock
- Documented and addressed any errors, omissions, or inconsistencies found during data review and worked with internal and external project teams to resolve issues as needed
- Maintained all necessary documentation to support accuracy of the clinical trial database
- Monitors and communicates project/program progress to Sponsor and project team, including project status reports and tracking tools/metrics to enable in-stream data collection and query management
- Performed activities following pre lock checklist to ensure all aspects of data have been reviewed to produce accurate and complete data for database lock
- Perform quality review and freezing and locking activities of data for interim and final database hard lock.
Clinical Data Manager
IQVIA
04.2020 - 07.2021
- Managed work to initiate, plan, and execute data management activities from study start-up to database lock
- Reviewed clinical study documentation protocols, CRFs, reports, and statistical analysis as part of review process
- Supported sponsor DM and other cross-functional leads like clinical operations in designing eCRF in accordance with protocol using CDISC/CDASH standards
- Created Edit check specifications and validated edit checks in EDC by performing User Acceptance Testing (UAT) in each study's eCRF parameters
- Developed and maintained eCRF completion guidelines (eCCGs) and Data Management Plan
- Developed data transfer specifications (DTS) or Data Transfer Agreements (DTA) with external vendors and coordinated data transfer activities
- Attended teleconferences and meetings with sponsor data management team
- Performed external vendor reconciliations like SAE, IRT, Lab, MRI etc
- Identified discrepancies, issued queries, and tracked query status until resolution
- Generated customized data reports by using J review/SAS listings
- Created Data Validation Specifications (DVS), reviewed data, and ensured timely submission of queries
- Performed quality control and assisted with reconciliation driving case closures
- Ensured data quality and consistency is maintained according to standard operating procedures (SOPs) and data standards
- Reviewed, monitored, and addressed data entry quality for accuracy and trends throughout the study
- Ensured data management procedures & projects have set timelines & meet established deadlines
- Collaborated with study team members to identify and resolve issues
- Involved and prepared Interim analysis reports and metrics during Interim Lock
- Responsible for supporting database locking activities using DB Lock Checklist, like planning and executing data listing reviews and identifying remaining clinical and monitoring tasks
- Performed Freezing and Locking of data for statistical review.
Clinical Data Coordinator
Bioclinica
03.2017 - 03.2020
- Reviewed protocols for clinical trial studies assigned
- Participated in various task forces during conduct and close-out phase of the study
- Assisted in developing annotated CRFs and CRF Completion Guidelines
- Participated in UAT and creation of edit check standards.
- Participated in creating project documentation like DMP, Data Validation documentation, CRF Completion Guidelines, and Data Transfer Agreements (DTA), as well as database designs and case report form creation
- Conducted external vendor data reconciliation for several clinical trials like PK, PD, Biomarkers, and exploratory data
- Resolved and recorded errors, discrepancies, or omissions discovered during data assessment
- Generated reports and data listings for study monitoring and regulatory submissions
- Performed data cleaning and quality checks to identify and resolve discrepancies
- Managed delivery of projects through full data management study lifecycle
- Resolved and recorded errors, discrepancies, or omissions discovered during reconciliation process
- Performed comprehensive data management tasks, including data review, querying, and resolving data clarifications
- Created reports to track study progress to ensure timeliness and quality expectations were met
- Developed and maintained good communication and working relationships with team
- Ensured compliance with regulatory requirements, including Good Clinical Practice(GCP) and Health Insurance Portability and Accountability Act (HIPPA)
- Participated in client meetings and other events relating to data management activities.
Education
Master of Science - Health Informatics
University of North Texas
University Of North TexasBachelor of Science - Pharm.D
Acharya Nagarjuna University
IndiaSkills
- EDC Platforms: Medidata Rave, Oracle Inform, Veeva Vault
- Safety Databases: Argus, Aris
- Data Visualization Tools: Elluminate, Spotfire
- MS: Excel, word, outlook, PowerPoint, Project
- J-Review/Custom Reports Generation
- Programming: Basic SAS, Python, SQL, Tableau
Accomplishments
- Diploma certification in Clinical Data Management
- Awareness in pharmacovigilance, organized by the UPSALA monitoring centre
- Good Clinical Practice (GCP) Certification
Timeline
Lead Clinical Data Manager
Fulcrum Therapeutics
05.2022 - Current
Clinical Data Manager
PPD
09.2021 - 04.2022
Clinical Data Manager
IQVIA
04.2020 - 07.2021
Clinical Data Coordinator
Bioclinica
03.2017 - 03.2020
Master of Science - Health Informatics
University of North Texas
Bachelor of Science - Pharm.D
Acharya Nagarjuna University
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