Ann Shaver Email and Phone Number

• Data Management Lead – Management and maintenance of clinical data; interfacing with clinical team; provide oversight from study start-up through statistical analysis by support of data capture, review and database lock activities; key point of contact for other study teams and contributing to adherence to milestones, other timelines and expectation of quality and accuracy.• External Vendor Manager – external vendor selection and performance acceptance; management and reconciliation of external data with regards to protocol and database collection• Process Owner/Subject Matter Expert – responsible for implementation and oversight of quality, efficiency and consistent approaches utilized for Clinical Data Management tasks. Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections.

• Data Management Lead – Management and maintenance of clinical data; interfacing with clinical team; provide oversight from study start-up through statistical analysis by support of data capture, review and database lock activities; key point of contact for other study teams and contributing to adherence to milestones, other timelines and expectation of quality and accuracy.• External Vendor Manager – external vendor selection and performance acceptance; management and reconciliation of external data with regards to protocol and database collection• Process Owner/Subject Matter Expert – responsible for implementation and oversight of quality, efficiency and consistent approaches utilized for Clinical Data Management tasks. Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections.

Collaborate with respective project sponsor and stakeholders to develop effective project plans to include scope, goals, deliverables, required resources, risks, issues and milestone timing. Effectively plan and execute multiple Data Management projects simultaneously. Provide updates directly to senior stakeholders as requested by line management. Assign tasks and responsibilities within Data Management to team members, in a manner that: optimizes team capability; delivers timely and accurate results; and supports the needs of the business. Ensure that assigned team executes Data Management functions in accordance with Chiltern and/or sponsor Standard Operating Procedures (SOPs). Provide guidance to less-experienced Project Data Managers. Clearly communicate expectations to team members and stakeholders. Resolve any issues and solve problems throughout project lifecycle. Manage sponsor relationships and triage issues as appropriate. Effectively manage project scope by ensuring any changes to scope are documented and approved through appropriate change management processes. Effectively lead a team of cross-functional associates towards common project goals. Proactively identify and address team cohesion obstacles to project success. Participate in and/or contribute to Sponsor and/or Regulatory audits/inspections. Participate/attend Sponsor requested meetings as required. Perform other duties as required by the Department.