MADHURI VAMMU
St. Thomas,Canada
Summary
Deeply knowledgeable in clinical data management with experience overseeing and organizing all aspects of clinical trial data. Possess strong skills in database designing, validation, and troubleshooting. Consistently ensure compliance with protocols, regulatory requirements, project deliverables and timelines. Proven ability to improve processes and streamline work for greater efficiency contributing positively to previous work environments.
Overview
10
10
years of professional experience
Work History
Clinical Data Manager
Syneos Health
, Canada
12.2021 - 07.2025
- Managed end to end clinical data management activities for global clinical trials {Phase I-III}.
- Performed data validation and cleaning using Medidata Rave, Veeva CDMS, and Oracle InForm.
- Conducted SAE Reconciliation by cross-checking clinical and safety databases to ensure alignment and assisted in medical coding using MeDRA and WHO Drug.
- Reviewed data listings, resolved data queries to ensure data accuracy and completeness.
- Participated in, and presents at internal, Sponsor, third-party, and investigator meetings.
- Maintained proficiency in Data Management processes through regular training.
- Supported database lock and Freeze activities through final data review and issue resolution.
- Coordinated with CRAs, Biostatisticians, and external vendors to ensure timely data delivery.
- Maintained compliance with SOPs, study protocols, and regulatory requirements.
- Prepare budgeting for the RFP.
- Conducted daily data review and raised/resolved queries using Medidata Rave, Veeva CDMS.
- Supported the development and execution of Data Management Plan {DMP} and Data Validation Specifications {DVS}.
- Participated in User Acceptance Testing {UAT} for eCRFs and provided feedback on system functionality.
- Clinical Data Manager {Remote}
Clinical Data Lead
Algorics Pvt Ltd {Contract} (Previously Omnicom Systems US)
Chennai
04.2018 - 11.2021
- Primary Data Management point of contact for day-to-day activity on study.
- Oversee and coordinate tasks delegated to the study team members.
- Provide training to new data management personnel on data management processes and procedures.
- Plan, manage, control and perform data processing and management activities for assigned projects. These tasks are performed in a timely and accurate manner and in compliance with trial Sponsors’ requirements.
- Creates and Develops study specifications, implementation, testing of eCRF or paper CRF edit checks and data review, overview listings.
- Accurately and efficiently validate electronically captured data. Write clear queries on missing data and data points failing pre-defined range checks and/or logical checks.
- Specify and review database edit check specifications for assigned studies.
- Provide training to new staff, study site and sponsor personnel on data management processes and procedures, data entry and review with electronic data capture systems, data flow and quality control processes.
- Maintain and prepare final archival of data management documentation relevant to the assigned clinical trials and assist the corporate archivist in assembling and archiving such documentation.
- Clinical Data Lead (REMOTE – CONTRACT)
Clinical Data Coordinator
Sunniva Life Science
Chennai, India
06.2015 - 11.2017
- Independently and accurately reviewed Case Report Form data for completeness, accuracy and consistency in accordance with all applicable procedures.
- Accurately and consistently applied data handling conventions to Case Report Forms as necessary in accordance with all applicable procedures.
- Performed Quality Reviews and appropriately address all issues. Compiled and distributed necessary study documentation and maintained accurate and completed study files in accordance with all applicable procedures.
- Identified and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings.
- Independently and accurately generated data queries to resolve data discrepancies.
- Appropriately address responses to data queries and accurately update the clinical data as necessary. Identified and accurately resolved all workflow or clinical data discrepant issues.
- Independently and accurately prepared database test documentation and test data entry screens. Assist with the validation of edit check programs. Assist with the development, review and the update of relevant Data Management Study Specific Procedures.
- Accurately performed Serious Adverse Event reconciliation in accordance with all applicable procedures. Accurately performed external data reconciliation in accordance with all applicable procedures.
- Generated and reviewed for accuracy and distribute status reports as requested.
Education
Postgraduate Diploma - Business Administration
York University
Toronto, ON09.2019
Postgraduate Diploma - Health Care Administration
Canadore College
Mississauga, ON09.2018
Bachelor - Pharmacy
Nirmala college of pharmacy, ANU
Guntur, India06.2016
Skills
- Clinical Data Review & Validation
- Query Management & Resolution
- SAE Reconciliation
- Data Cleaning & Discrepancy Management
- EDC System: Medidata Rave, Veeva CDMS
- Excel, SAS, Clinical Database Tools
- Study Documentation {DMP, DVS, Edit Checks}
- Cross-Functional Communication
- ICH-GCP & Regulatory Compliance
Therapeutic Areas:
- Cardiovascular - Heart Disease, Ischemic
- Neurology - Fragile X Syndrome
- Oncology - Cancer, Acute Lymphocytic Leukemia
- Ophthalmology - Myopia
- Women's Health - Fertility
- Women's Health - Uterine Fibroids
Timeline
Clinical Data Manager
Syneos Health
12.2021 - 07.2025
Clinical Data Lead
Algorics Pvt Ltd {Contract} (Previously Omnicom Systems US)
04.2018 - 11.2021
Clinical Data Coordinator
Sunniva Life Science
06.2015 - 11.2017
Postgraduate Diploma - Business Administration
York University
Postgraduate Diploma - Health Care Administration
Canadore College
Bachelor - Pharmacy
Nirmala college of pharmacy, ANU
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