Provide leadership and guidance to internal design, development, and testing teams utilizing SDLC standards for initial IXRS builds and sub-buildsFacilitate discussions with client and internal design team for implementing initial IXRS study builds, documenting all stakeholder decisionsParticipate in decision making for design customizations of established IXRS systemsEstablish and manage project schedules, ensuring compliance of internal team members, communicating any… Show more Provide leadership and guidance to internal design, development, and testing teams utilizing SDLC standards for initial IXRS builds and sub-buildsFacilitate discussions with client and internal design team for implementing initial IXRS study builds, documenting all stakeholder decisionsParticipate in decision making for design customizations of established IXRS systemsEstablish and manage project schedules, ensuring compliance of internal team members, communicating any anticipated changes with all stakeholdersCreate and manage the completion of risk assessments with internal team members for initial and sub-builds and consider delivery and design riskManage risk throughout maintenance phase of study via established internal processes, such as completing monthly health checks and live project reviewsCoordinate with client internal design team to ensure UAT scripts are received and reviewed for data setupReview and confirm UAT memo issued to client includes correct build and internal CR identifiers, and document any outstanding builds not covered in the current UATWork with internal data services development team members to resolve issues with and establish new data transfers (InForm EDC, Merck Nextgen, EOT data transfers)Coordinate with internal clinical services team members to establish drug supply standards for IXRS initial builds and communicate monthly to ensure supply stabilityEstablish monthly maintenance meetings to discuss study’s health throughout the maintenance portion of the life cycle with client stakeholdersEnsure support Quick Reference Documents are correct and updated, available to client end users on the IXRS siteRespond to client and internal teams service requests in a timely manner to resolve or set a timeframe for resolution Show less

Tracked IXRS deliverables including URS, Communication Plans, and Drug Shipment Details for multiple studies quality gates, based on SDLC WIs and SOPs, ensuring timely QA reviewCompleted quality review of all CPS documentation, verifying controlled documents are finalized and signedAssisted QA with data stewardship activities to maintain and optimize data quality across all IXRS builds or iterationsRecorded assigned study team members in TFS, establishing team member’s… Show more Tracked IXRS deliverables including URS, Communication Plans, and Drug Shipment Details for multiple studies quality gates, based on SDLC WIs and SOPs, ensuring timely QA reviewCompleted quality review of all CPS documentation, verifying controlled documents are finalized and signedAssisted QA with data stewardship activities to maintain and optimize data quality across all IXRS builds or iterationsRecorded assigned study team members in TFS, establishing team member’s discipline and capacityEstablished queries in TFS for 3.0 IXRS to eliminate QA findings prior to study going liveManaged IXRS translation process, with Language Associates and Project ManagersCompleted authorship of Study Maintenance Plan/Project Scope & Management, based on study URS, requirements, and client feedbackRecorded and distribute minutes for URS review with internal and external stakeholders, during requirements gathering stage of the projectEnsured completion of Support Group deliverables requests, based on SDLC timelinesAttended internal status meetings, with key stakeholders, confirming timeline compliance and identifying potential risks for seamless execution of deliverablesProvided weekly Project Manager Workload Report for GL and managerial reviewCompleted monthly Health Checks for multiple studies, and issue to assigned Group LeadersRecorded and distributed minutes recorded for the bi-weekly 3.0 IXRS Design Manager forumProvided guidance and mentorship to new Project Coordinators and new Project Managers Show less

Regulated and processed confidential IXRS user information provided by external clientsCreated and controlled IXRS upload components for site users and depot imports based upon strict study timelinesLead meetings with external sponsor teams, instructing on IXRS end user functionalityEstablished initial IXRS alerts to study end users, based on URS requirements within the IXRS production environmentPerformed metadata review during a study’s implementation phase of… Show more Regulated and processed confidential IXRS user information provided by external clientsCreated and controlled IXRS upload components for site users and depot imports based upon strict study timelinesLead meetings with external sponsor teams, instructing on IXRS end user functionalityEstablished initial IXRS alerts to study end users, based on URS requirements within the IXRS production environmentPerformed metadata review during a study’s implementation phase of the SDLCCoordinated with project management teams, ensuring study documentation qualityCoordinated with Clinical Supply teams to establish site resupply data, based upon country or regional supply strategiesProvided training and mentorship to new and tenured colleagues Show less

Assisted external IXRS end users with performing transactions via phone and/or webConfirmed IXRS functionality, based on URS/PRS/BR requirements and expected product capabilities for each study specific buildManaged identification and resolution of IXRS system errors and data inquiries for internal and external teamsPerformed as the department SME for Merck Sharpe & Dohme client IXRS standardsProcessed client user management requests in coordination with… Show more Assisted external IXRS end users with performing transactions via phone and/or webConfirmed IXRS functionality, based on URS/PRS/BR requirements and expected product capabilities for each study specific buildManaged identification and resolution of IXRS system errors and data inquiries for internal and external teamsPerformed as the department SME for Merck Sharpe & Dohme client IXRS standardsProcessed client user management requests in coordination with associated departmentsMonitored and provided outreach to depots regarding outstanding depot-to-site shipmentsCreated and issued IXRS user access for both internal and external end userTrained internal stakeholders in TSR functions and IBM COGNOS reports administration Show less