Sai Ramavath
Oakville,ON
Summary
Seasoned clinical data management professional with 8+ years of experience in Phases I, II, and III across diverse therapeutic areas such as oncology, cardiovascular, immunology, and dermatology. Proficient in Agile methodology, SAS data review, and EDC platforms to ensure accuracy and efficiency in Real-World Data and Clinical Trials.
Overview
9
9
years of professional experience
Work History
Senior Data Manager
Emmes
04.2022 - Current
- Served as the primary point of contact for assigned studies, leading end-to-end oversight of project management activities, including study startup tasks and data cleaning in preparation for database lock.
- Led data management team meetings to discuss project status, identify issues, and propose solutions.
- Provided training to new data management personnel on data management processes and internal data audits.
- Responsible for issuing queries, study database design, discrepancy management, data reconciliation, and overseeing the reporting of AEs/SAEs.
- Contributed to designing and reviewing essential project materials such as protocols, MOPs, user guides, CRFs/eCRFs, ensuring adherence to strict standards.
- Authored and reviewed edit checks, and maintained eCRF completion guidelines, Data Management Plans (DMPs), and Data Validation Plans (DVPs).
- Performed thorough User Acceptance Testing (UAT) for eCRFs and on associated edit checks.
- Conducted process improvement and training for staff to improve reporting methods.
- Designed customized web reports and Data Transfer Plans (DTP) in accordance with vendor requirements.
- Monitored project progress closely, ensuring that milestones were achieved within specified timelines, resulting in high-quality outcomes aligned with project standards.
- Adhered to tight timelines for regulatory submission.
- Led direct negotiations with customers on timelines, financial processes, and resources.
- Independently managed data management service delivery with comprehensive expertise in executing projects.
- Acted as the escalation point for unresolved data issues, working with client data managers, vendors, and internal team members for resolution.
- Created and reviewed key deliverables including Data Management Plans (DMPs) and ensured compliance with contractual obligations.
- Established and maintained strong communication with Data Operations team, functional leads, and stakeholders to ensure seamless project execution.
- Provided leadership and vision to the team in areas of project planning, execution, and close-out.
- Ensured proper resource allocation to meet project deliverables within budget constraints.
- Mentored junior team members to strengthen their understanding of data management processes.
- Facilitated internal audits to ensure adherence to Good Clinical Practices (GCPs), applicable regulatory guidelines, and company SOPs.
- Implemented process improvements that enhanced team productivity and data quality.
Senior Clinical Data Manager
Endo Pharmaceuticals
10.2019 - 03.2022
- Ensure that staff has the proper materials, systems access and training to complete job responsibilities
- Handled data transfers from external vendors
- Identified Out of scope activities and notified the client
- Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff
- Involved in handling resource management in the studies
- Created Study metrics to monitor study progress to ensure the expectations are met as per the timeliness and quality
- Provided inputs for improving the operational process and workflow, while maintaining the quality outcomes
- Always kept the studies inspection ready, by maintaining study specific documents adhering to the organizational process
- Developed study specific database requirements and edit check requirements
- Work closely with clinical database programmers to provide specifications at the time of study database development
- Created and maintained data management plans, Data Review guidelines and other studyspecific work instructions or guidelines for multiple projects
- Responsible for the design and development of Case Report Forms (CRF) in collaboration with CRAs or Clinical Project/Program Managers
- Contract
Clinical Data Analyst
CLINIZTECH Research Solutions Pvt Ltd
08.2015 - 07.2019
- Worked with database developers in designing the CRF, testing and implementation of the study specific and protocol specific CRFs in databases
- Pro-actively involved in testing various Edit Checks as part of the UAT or System testing
- Identified discrepancies, issued queries, tracked queries and incorporate query replies
- Involved in reviewing and validating data in accordance with the Data Validation plan and Data Management Plan to ensure database consistency and accuracy
- Generated electronic queries to appropriate internal or external personnel (e.g.: investigational sites, Clinical Research Associates) to resolve problematic data identified during various aspects of the data management process
- Performed soft lock and hard lock of the database at the completion of the study after thorough QC of data
- Generated reports using reporting tools like J-Review
- Ensure compliance to Data management guidelines and departmental SOP's
- Performed data management tasks: data review, discrepancy management, listing review, quality control and reported status reports to client
- Responsible for performing Database User Acceptance Testing (DB UAT) and Edit Check User Acceptance Testing (EC UAT) for the assigned studies
Education
Post Graduation Diploma - Supply Chain Management
Fanshawe College
Bachelor - Civil Engineering
TRK Engineering College
Skills
- Experience in working on Advantage eClincal, InForm and RAVE databases
- Agile Methodologies
- Problem solving capability by identifying the root cause
- Stakeholder Management
- Good Clinical Practice (GCP)
- Microsoft Excel
- SAS (Software)
- SQL
- SAE Reconciliation
- Data Validation
Languages
English
Full Professional
Hindi
Native or Bilingual
Timeline
Senior Data Manager
Emmes
04.2022 - Current
Senior Clinical Data Manager
Endo Pharmaceuticals
10.2019 - 03.2022
Clinical Data Analyst
CLINIZTECH Research Solutions Pvt Ltd
08.2015 - 07.2019
Bachelor - Civil Engineering
TRK Engineering College
Post Graduation Diploma - Supply Chain Management
Fanshawe College
Similar Profiles
Matthew LahutMatthew Lahut
Programmer Analyst at EMMESProgrammer Analyst at EMMES
Charles DieukensCharles Dieukens
Camera Intercom Installer at EmmesCamera Intercom Installer at Emmes
Willow AzoozWillow Azooz
Manager, Clinical Data Management at EmmesManager, Clinical Data Management at Emmes
Shirley ChenShirley Chen
Account Director at Moseiko Canada Inc.Account Director at Moseiko Canada Inc.
Fizah ShahidFizah Shahid
Technical Consultant at PointClickCare TechnologiesTechnical Consultant at PointClickCare Technologies