Alice Bartuska Email & Phone Number

• Ensure appropriate MedDRA and WHODrug coding for multiple studies• Interact with and oversee vendor to ensure timely, accurate and consistent medical coding • Participate in the review and approval of coded terms for all active studies• Contribute to the upkeep of cSMQs by identifying and updating terms accordingly• Participate in dictionary up versioning activities including identifying and performing remaps• Lead cleanup of MedDRA synonym table by identifying and… Show more • Ensure appropriate MedDRA and WHODrug coding for multiple studies• Interact with and oversee vendor to ensure timely, accurate and consistent medical coding • Participate in the review and approval of coded terms for all active studies• Contribute to the upkeep of cSMQs by identifying and updating terms accordingly• Participate in dictionary up versioning activities including identifying and performing remaps• Lead cleanup of MedDRA synonym table by identifying and addressing inconsistencies• Lead remapping of over 50,000 WHODrug terms for study migration Show less

• Utilized analytics/visualizations to review aggregate data for the assessment of Risk Indicators • Identified, tracked, communicated and escalated findings as appropriate• Participated in study RACT development• Supported global inspection readiness and inspections/audits regarding RBM/RBQM• Contributed to the development of the Risk Indicator Library• Contributed to the development of the Centralized Monitoring Strategy Plan template • Led and supported cross… Show more • Utilized analytics/visualizations to review aggregate data for the assessment of Risk Indicators • Identified, tracked, communicated and escalated findings as appropriate• Participated in study RACT development• Supported global inspection readiness and inspections/audits regarding RBM/RBQM• Contributed to the development of the Risk Indicator Library• Contributed to the development of the Centralized Monitoring Strategy Plan template • Led and supported cross functional workstreams for implementation of new tools/systems• Led and supported the development and revisions of RBM/RBQM process documents• Mentored new Central Monitors• Participated in interviews and candidate selection for new hires to the Central Monitoring team• Business Lead of support workstream for implementation of Medidata applications partnering with BMS and Medidata IT leads to ensure all functional area business needs were addressed• Business Co-Lead with GBS partner of integrations workstream for implementation of Clinical Data Workbench (CDW), Metadata Repository (MDR) and Clinical Data Repository (CDR)• Business Lead for Digital Acorn Bring Your Own Device (BYOD)/Wearables Workstream to identify use cases for utilization of these tools in clinical studies Show less

• Managed a team of up to 21 Data Managers in objective setting, performance and development • Coordinated resourcing and hiring activities• Drove the development and implementation of new roles, standards and processes into the organization by leading or supporting many departmental objectives• Co/Tri-Lead of the Data Execution/Quality Operations Forum which was a cross functional team overseeing and establishing data review processes and metrics at the organizational… Show more • Managed a team of up to 21 Data Managers in objective setting, performance and development • Coordinated resourcing and hiring activities• Drove the development and implementation of new roles, standards and processes into the organization by leading or supporting many departmental objectives• Co/Tri-Lead of the Data Execution/Quality Operations Forum which was a cross functional team overseeing and establishing data review processes and metrics at the organizational level• Business Owner of Study Management Tools (BMS developed CRF tracking system) collaborating and negotiating with IT and end users to ensure appropriate functionality of the tool Show less

• Managed a team of up to 21 Site and Data Managers in objective setting, performance and development • Coordinated resourcing and hiring activities• Drove the development and implementation of new roles, standards and processes into the organization by leading or supporting many departmental objectives• Co/Tri-Lead of the Data Execution/Quality Operations Forum which was a cross functional team overseeing and establishing data review processes and metrics at the organizational… Show more • Managed a team of up to 21 Site and Data Managers in objective setting, performance and development • Coordinated resourcing and hiring activities• Drove the development and implementation of new roles, standards and processes into the organization by leading or supporting many departmental objectives• Co/Tri-Lead of the Data Execution/Quality Operations Forum which was a cross functional team overseeing and establishing data review processes and metrics at the organizational level• Business Owner of Study Management Tools (BMS developed CRF tracking system) collaborating and negotiating with IT and end users to ensure appropriate functionality of the tool• Maintained responsibilities noted below for Protocol Data Manager Show less

• Drove the data review strategy and data management activities from start-up through database lock for multiple global studies (such as performing or overseeing CRF and edit check development, Data Review Plan creation, data review, discrepancy management, CRF and query tracking, SAE reconciliation, etc.)• Prepared materials for and presented at Investigator Meetings• Contributed to the development of standards for data collection and cleaning at program and global levels• Provided… Show more • Drove the data review strategy and data management activities from start-up through database lock for multiple global studies (such as performing or overseeing CRF and edit check development, Data Review Plan creation, data review, discrepancy management, CRF and query tracking, SAE reconciliation, etc.)• Prepared materials for and presented at Investigator Meetings• Contributed to the development of standards for data collection and cleaning at program and global levels• Provided mentoring, training and coaching to global data managers • Acted as subject matter expert for multiple departmental and cross functional initiatives• Coordinated and participated in UAT and implementation of various processes and systems Show less

• Reviewed CRFs for standardization• Created protocol databases in Oracle Clinical to ensure appropriate collection of study data• Prepared annotated CRFs and database review package• Wrote system requirements and participated in UAT for Oracle Clinical reports• Created ETL mappings to migrate data from Oracle Clinical to eDAD (reporting repository)• Presented database development functions at various forums

• Contributed to the development of processes and structure for newly created DMO group responsible for CRF imaging and data entry across all TAs• Managed a team of 20+ Data Examiners in daily activities and conducted performance reviews• Provided training on various processes• Communicated procedural information to appropriate stakeholders• Oversaw, prioritized and performed imaging, indexing and entry of CRFs, CTFs and FCFs to ensure study milestones were achieved for all… Show more • Contributed to the development of processes and structure for newly created DMO group responsible for CRF imaging and data entry across all TAs• Managed a team of 20+ Data Examiners in daily activities and conducted performance reviews• Provided training on various processes• Communicated procedural information to appropriate stakeholders• Oversaw, prioritized and performed imaging, indexing and entry of CRFs, CTFs and FCFs to ensure study milestones were achieved for all studies across all TAs• Reviewed draft CRFs across TAs for standardization• Performed UAT of databases for new protocols• Wrote system requirements and performed UAT for implementation of new Oracle Clinical and PC Imaging systems Show less

• Identified and addressed data issues• Performed data entry and updates of clinical data from CRFs, CTFs and FCFs• Performed medical coding of CRF reported terms• Participated in UAT for implementation of new Clintrial system• Performed UAT of Clintrial databases for new protocols