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• Manage DM activities performed at CRO and vendors to ensure delivery against contracted scope of work• Provide timely and professional ongoing management of clinical trial data perfumed the CRO to the managements by preparing validation plans and chairing meetings• Perform protocol training to the CRO and vendor during study startup and communicate resource issues and timeline to manager• Manage data and related deliverables for a portfolio of studies, tracking timelines and deliverables• Manage custom software configuration and database building with strong understanding of clinical study protocol schedule of assessments• Provide input and participates in development of clinical study documents including protocol and monitoring plans• Create manual discrepancies and facilitate and coordinate tele-conference meeting with CROs to update on project metrics• Ensure UAT is carried out and documented including creating UAT script for testing data entry screens and edit checks• Monitor discrepancy management to ensure appropriate quality of data by regular checks during study conduct versus the data quality plan

Canada

-Supporting the execution of the Data Management strategy from DB set-up to lock along with the good understanding/coordination across the Data Management technology set-up for the project. -Define and monitors metrics and modifies plan accordingly. -Set up and participate in cross functional meeting, Initiate PD review meeting -Initiate client calls. -Direct team members in daily activities -Effectively communicate to and manage internal project teams, external customers and third-party vendors. -Review metrics reports regularly and send the updates to Client. -Lead and participate in the kick of meetings for set-up projects. -Mentor project team members. -Perform and or support the setup of DM documents and ensure proper documentation. -Management of project timelines (including creation, review and tracking of plans). -Ensure the study team list is up to date and the appropriate trainings have been assigned to the team in LMS system before team kick start on project activities. -Extensively experienced in creating critical study documents of Data Validation Specification, Protocol deviation specification, Study design requirement, Data Cleaning Specification, CRF Completion Instruction, SAE Recon plan, test scripts, test cases, postproduction revision requests. -Other responsibility includes coordination of the relevant Data Operations team members, liaising with project leadership placed globally other functional leaders (clinical biostatistics, medical, medical writing etc.) and the client as a single point of contact to ensure that the contracted data deliverables are being met – specifically in terms of timeliness, financial management and quality.-Performed Database Quality Assessment Activity -Perform and maintain trackers of formal quality check of team members to ensure database quality.

-Support and assist data management staff for allocated trials -Input to and review of clinical trial database design including User Acceptance Testing (UAT). -Understand the data management requirements of the protocol to perform Data Management tasks -Identify errors and inconsistencies; resolve them or initiate their resolution either via the field monitor or directly with the investigational site, to ensure high quality and timely database locks. -Freeze and lock data as appropriate in time for statistical review, interim and final database lock. -Track and report status of tasks assigned and progress of data management activities for assigned trials to ensure timely locking of databases. -Providing the metrics tracker and study reports to Study Lead and sponsor and taking their valuable feedback. -Organize teleconference, team meetings with Onshore/offshore, counter parts as required. -Arrange team meetings with study team members and discuss the project related issues regularly and document them as MOM. -SAE reconciliation, reviewing all the external data [LAB and ECG], IVRS reconciliation, Listings (SAS and Manual Listings, Ad-hoc Reports, UAT, DVS writing, Functional QC for multiple studies including SDTM mapping, Coding Functional QC activities, Test Script writing, Test data creation, Test data entry).