• Managing Scope of work (SOW), budgets, forecasts, timeline, deliverables, milestones, quality and risks assigned forCDM/ePRO studies• Participating in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level ofsupport, communication provided• Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry andreporting of clinical data.• Develops test scripts and execution logs for… Show more • Managing Scope of work (SOW), budgets, forecasts, timeline, deliverables, milestones, quality and risks assigned forCDM/ePRO studies• Participating in Study Kick Off meetings and Clinical Trial Team meetings for the assigned trials ensuring appropriate level ofsupport, communication provided• Participated in designing Electronic Data Capture (EDC) databases and ensured they meet requirements for the entry andreporting 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, databaseupdates, 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 dummydata to evaluate EDC database functionality Show less

• 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… Show more • 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 andoversight 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 Show less

• 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… Show more • 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 data clarifications.• 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. Show less