Lakshmi Devi D Email & Phone Number

Canada

- Managing Scope of work (SOW), budgets, forecasts, timeline, deliverables, milestones, quality and risks assigned for CDM/ePRO studies.- Participating in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level of support, communication provided.- Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry and reporting of clinical data.- Develops test scripts and execution logs for User Acceptance Testing (UAT) and performed UAT on forms and edits for new studies in the Development phase.- Potentially interact and collaborate with other project and specialty team members (clinical, programming, statistics, CDM technical support, drug safety, etc.) to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.- Performed all aspects of data management tasks for multiple studies including data query, query resolutions, database updates, data base audits and data transfers.- Participated in study data review including identification, resolution and clarification of any missing, inconsistent or clinically questionable data.- Ensured high quality data for timely clinical trial analysis and reporting; plans, coordinates, and executes strategies to optimize database performance.- Builds study databases, programs edit checks and data validations.- Oversees query management in collaboration with clinical operations personnel.- Create, review, and/or execute Form and Edit Check Specification User Acceptance Testing by creating/reviewing dummy data to evaluate EDC database functionality.

Canada

- Provided input in study protocol design related to data collection and data management.- Ensured that each clinical study database is designed in accordance with the database definitions outlined in the DMP.- Involved in identifying and contributing to the development of study specific CRFs, database documentation, edit check specifications, data handling conventions and data entry instructions.- Performed all data management activities with no or minimal supervision, including but not limited to database development, testing, validation, site training and support, query resolution, audit, lock, and archive.- Lead the development of specifications, implementation, and testing for the eCRF, the edit checks and data review and oversight listings (DVS).- Coordinated and completed data management activities to meet project timelines.- Reconciles query issues, adverse events and serious adverse events.- Maintained more than 4-5 study databases and data management activities concurrently.- Filed and maintained CRFs, subject diaries, and other subject-specific documentation collected during clinical studies.- Assisted in clinical study CRF related summary and listing reports using related software- J review listings.- Provided guidance and mentorship to less experienced and/or entry-level Associates of Clinical Data Management.- Lead development of the data management plan and study specific procedures.

India

- Primary Data Management point of contact for day-to-day activity on study.- Lead and conduct all end-to-end CDM activities (Study build, Conduct & Lock) for assigned clinical studies.- Oversee and coordinate tasks delegated to the study team members according to the budget provided.- Activities that involve are managing projects and team, meeting timelines/deliverables with Quality, writing eCRF completion guidelines, writing test plan for Data validation specifications and testing.- Query management, Vendor management, SAE management, QC, primary contact for programmers, vendors and Clinical team, handling Data transfers, Datasets review.- Study communication with Project Team (Project Lead, Primary Clinical Data Analyst, Data Operation Lead, Clinical Operation Lead, CRA, Medical Operation Lead and Statistical and Database Programmers).- Managed delivery of projects through full data management study life cycle.- Performed comprehensive data management tasks including data review, writing and resolving dataclarifications.- Performed comprehensive quality control procedures.- Independently bring project solutions to the CDM team.- Solved issues through using the global issue escalation/communication plan.- Understand and complied with core operating procedures and working instructions.- Developed and maintained good communications and working relationships with CDM team.- Interacted with CDM team members to negotiate timelines and responsibilities.- Trained and mentored team members.- Identified and reported protocol deviations.- Conducted reconciliation of SAEs, send out queries as required and notify relevant Safety Groups of possible issues for their action.- Performed UAT, writing test cases and executing them.- Involve in creation and responsible in maintenance of study files and other study documents in company specific storage database.

India

- Designed case report forms (CRFs).- Involved in the preparation of DMP and eCRF completion guidelines and other DM related documents.- Responsible for performing the Database lock activities, like planning and executing listings review, identifying remaining clinical and monitoring tasks.- Performed Quality Check (QC) of the data by manual review. Generated and reviewed EDC/UAT functionality and Edit Checks. Developed and executed queries in clinical databases.- Created and reviewed CRF Completion Guidelines document. Performed Lab, SAE and external-vendor data reconciliation in several clinical trials.- Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out. - Played a key role in closing database lock.

Pg Diploma, Healthcare Informatics And Leadership For Healthcare Professionals

Bachelor Of Dental Surgery