Trupti Mahankuda
Clinical Database Programmer II
Bangalore,Karnataka
Summary
Driven Database Developer with 4 years of proven success designing and implementing database solutions. Analytical and skilled in understanding business problems to develop systems that improve functionality. Talented at working effectively in collaborative and self-motivated environments.
Having around 10 Years of experience in clinical data management, Proficient in all Data management activities from EDC build, conduct and close-out phase. Highly involved in eCRF design review and provide input to improvise the design as required per protocol. Experienced in Medidata Rave, Medrio, InForm, platforms. Creation of Data Management Plan, eCRF completion guidelines, External data transfer specifications, vendor handling/communications, Managed full project life cycle, DSMB, LPLV to DB lock, database quality check, team utilization, productivity
Overview
12
12
years of professional experience
1
1
Certification
3
3
Languages
Work History
Clinical Database Programmer - II
PAREXEL International
11.2021 - Current
- Create, implement and execute procedures to build and maintain database set-up for web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable and programming in edit checks
- Work on Study Migration and Revision Requirements
- Maintain all supporting documentation for studies in accordance with SOPs/Guidelines/Work Instructions to ensure traceability and regulatory compliance
- Accountable for first time quality on all deliverables
- Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines
- Assist in providing technical solutions to internal or external client enquires
- Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting and other programming language usage and processes within the GDO area
- Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized
- Maintain technical documentation that is applicable to the Clinical Database
- Participate in the creation of standards, either through tools, libraries or processes, as required for GDO to ensure efficient, effective and optimal processes.
Lead Data Manager
Quartesian Research PVT Ltd.
04.2020 - 10.2021
- Working as a sponsor Lead and perform oversight of Data Cleaning Activities
- Tracking milestones and tasks for assigned projects
- Reconciliation of data cleaning metrics report and Milestone tracing
- Oversight and review of SAE reconciliation
- Preparation of study status on a regular basis
- Perform review of third-party data, Protocol Deviations, External Data Reconciliation Trackers
- Facilitate regular DM meeting with vendor and take updates on data cleaning
- Run patient profile, DM cleaning reports, study data extraction
- Act as point of contact for any study related approvals
- Perform UAT activities
- Perform SAS reconciliation validation programs and vendor External Data QC.
Senior Clinical Data Coordinator
Icon Clinical Research PVT Ltd.
06.2017 - 03.2019
- Serving as primary client liaison for Data Management issues
- Tracking milestones and tasks for assigned projects
- Tracking overall budget for assigned projects
- Ensuring timely completion of all project status reporting
- Interfacing with internal team members across all departments as needed
- Providing study specific, including protocol training, to extended Data Management team members as appropriate
- Attending client kick off and investigator meetings as required
- Ensure QC steps are implemented so quality deliverables are provided
- Ensuring project deliverables are achieved in terms of timelines and quality
- Identifying and negating study issues early
- Providing system demonstrations as needed
- Understanding the Data Management technology sales strategy and using the information effectively in Business Development meetings
- Performing core DM activities
- Performing UAT and Creation of Edit specification test plan, creation of test cases.
Clinical Data Associate 3
PPD Pharmaceuticals
09.2014 - 04.2017
- Serving as Primary Data Associate for multiple projects
- Performing SAE Reconciliation, Third Party Data Reconciliation
- Edit Checks Test Cases Creation and Validation
- Performing Listings Validation (Manual Listings, SAS listings)
- Creation of eCRF Guidelines
- Develop and test databases and edit specifications
- Performing Database Lock activities
- Responsible for Completeness, Timely Delivery and Quality of Clinical Data
- Understand and comply with core operating procedures and working instructions
- Meet objectives as assigned.
Associate Clinical Data Analyst
IQVIA
03.2012 - 02.2014
- Writing test cases, and performing UAT
- Performing eCRF Validation, System Settings, Rights and Roles Validation
- Performing SAS entry
- Performing Discrepancy Management
- Performing Listings Validation (Manual Listings, SAS listings)
- Producing automated and manual data queries
- Develop and test databases and edit specifications
- Understand and comply with core operating procedures and working instructions.
Education
B.S in Nursing (R.N) -
MKCG Medical College of Nursing
Post Graduate Diploma in Computer Application -
Government Of Odisha
Post Graduate Diploma in Clinical Data Management - undefined
Date Of Joining
11/08/21
Therapeutic Area Expertise
- Cardiovasular, II, 2 years, US, Data Management
- Autoimmune, I, II, 3.5 Years, US, Data Management
- Endocrinology, III, 2 Years, Japan, Data Management
- Respiratory, II, 2.3 Years, UK, Data Management
- Medical Device, II, 1 Year, US, Data Management
Summary Of Experience
Having around 10 Years of experience in clinical data management, Proficient in all Data management activities from EDC build, conduct and close-out phase. Highly involved in eCRF design review and provide input to improvise the design as required per protocol. Experienced in Medidata Rave, Medrio, InForm, platforms. Creation of Data Management Plan, eCRF completion guidelines, External data transfer specifications, vendor handling/communications, Managed full project life cycle, DSMB, LPLV to DB lock, database quality check, team utilization, productivity
Certification
Medidata Classic Rave Certified Builder
Timeline
Medidata Classic Rave Certified Builder
05-2023
Clinical Database Programmer - II
PAREXEL International
11.2021 - Current
Lead Data Manager
Quartesian Research PVT Ltd.
04.2020 - 10.2021
Senior Clinical Data Coordinator
Icon Clinical Research PVT Ltd.
06.2017 - 03.2019
Clinical Data Associate 3
PPD Pharmaceuticals
09.2014 - 04.2017
Associate Clinical Data Analyst
IQVIA
03.2012 - 02.2014
B.S in Nursing (R.N) -
MKCG Medical College of Nursing
Post Graduate Diploma in Computer Application -
Government Of Odisha
Post Graduate Diploma in Clinical Data Management - undefined
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