Sherry Schulz Email and Phone Number

• Development and implementation of strategy for relationships with site networks.• Develop and implement the Prime Site strategic plan promoting growth and differentiation, working with the site to execute the strategic imperatives of the plan including enhancements related to patient contribution, protocol density, timelines, infrastructure, and quality.• Maintain and share metrics as well as pipeline information with the Prime Sites on a routine basis.• Identify opportunities for Prime Sites to participate in studies that match site capabilities, by collaborating with therapeutic area/project strategy teams. Work to adjust Prime Site capabilities to study portfolio, actively liaising with internal and external stakeholders.• Point of contact for Governance teams, senior stakeholders and site staff. Participate and organize Joint Executive Steering Committee (JESC) and Joint Operational Steering Committee (JOSC) meetings• Collaborate with other IQVIA team members, working with the Prime Sites, to overcome any site related barriers and challenges that affect the ability of the site to produce quality project deliverables in an effective, efficient and timely manner.• Share information and provide efficient communication with delivery teams, resolve site issues that have been escalated by the CRA or project teams.• Ensure IQVIA processes integrate with those of the site. Support adoption of IQVIA systems by sites, or with support, create and execute guidance and solutions for internal teams when this is not possible.• With support, identify and explore differentiating factors within the Prime Sites that can be developed to create new/innovative business opportunities.• Promote Prime Site internally and externally, maintaining its visibility and image, position in the market, and liaise with KOLs and site therapeutic teams to win work and support Prime Site expansion.

(merged from legacy role Associate Manager, Site Network)• Manage key strategic site relationships in order to build capability, drive productivity and robust quality management in line with site strategy.• Manage, develop, coach, and motivate CRAs to develop their skills to ensure that a high professional standard is achieved and project targets are met.• Implement strategies and action plans to maximize delivery of a high quality team, ensuring achievement of individual/team/department targets, aligning with company strategies.• Provide concierge service to sites including regular face-to-face visits.• Concentrate more projects into fewer sites through improved capabilities for enhanced recruitment performance.• Conduct Accompanied Site Visits to develop CRA skills and advise on critical specific study issues.• Identify quality risks and issues and suggest appropriate corrective action plans to senior management to prevent or correct deficiencies in performance of employees.• Ensure that staff have the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan and mentored training experiences.• Ensure timely and accurate reporting of required information on company systems. Maintain systems compliance and oversight for effective project delivery.• Management of staff in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; gathering feedback for appraising performance, guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.

• Assigned to large phase 3 risk-based monitoring program• Guided and directed the work of CRAs on site as well as providing mentoring to ensure quality deliverables of assigned CRAs.• Oversight of CRA compliance with remote monitoring processes on risk-based monitoring study.• Ensued that clinical monitoring tasks were conducted in accordance with protocol, process, quality standards and expectations, per contract.• Conducted site monitoring visits as needed.• Developed CRA facing guidance documents and materials (i.e. site visit report annotations, visit guidelines, & letter templates).• Acted as subject matter expert for operational conduct of the assigned protocol.• Onboarded newly assigned CRAs.

• Performing site monitoring activities for phase 2 and 3 studies including Pre-Qualification Visits, Site Initiation Visits, Site Monitoring Visits, Drug Accountability, and Close-Out visits with emphasis on ICH-GCP compliance.• Preparation of sites for Sponsor, Quality Assurance, and Food and Drug Administration (FDA) audits.• Working with sites to provide strategies to enhance recruitment.• Using multiple industry-leading electronic Data Capture (eDC) systems including InForm, Oracle RDC, and MediData RAVE.• Providing training to new CRAs as a CRA mentor.

• Assigned to global phase 3 HIV program• Guided and directed the work of CRAs on site as well as providing mentoring to ensure quality deliverables of assigned CRAs.• Oversight of CRA compliance with monitoring processes• Ensured that clinical monitoring tasks were conducted in accordance with protocol, process, quality standards and expectations, per contract.• Conducted site monitoring visits as needed.• Acted as subject matter expert for operational conduct of the assigned protocol.• Onboarded newly assigned CRAs.• Collaborated with Sponsor representatives• Planned and delivered the clinical component of the project on time• Review of site visit reports (SVRs)• Development of project-specific work instructions/procedures and project training

• Performing site monitoring activities for phase 2 and 3 studies including Pre-Qualification Visits, Site Initiation Visits, Site Monitoring Visits, Drug Accountability, and Close-Out visits with emphasis on ICH-GCP compliance.• Preparation of sites for Sponsor, Quality Assurance, and Food and Drug Administration (FDA) audits.• Working with sites to provide strategies to enhance recruitment.• Using multiple industry-leading electronic Data Capture (eDC) systems including InForm, Oracle RDC, and MediData RAVE.

• Performed full range of site monitoring activities for Phase II HIV studies.• Edited clinical trial protocols for investigational biologics for Phases I, II, and III• Preparation of presentations and activities for investigator meetings• Review of vendor data validation specifications and Data Management Plans (DMPs) for Code of Federal Regulations (CFR) Part 11 complianceOther duties included:• Directed network upgrade (23 users) including implementation of Virtual Private Networking (VPN), Microsoft Exchange, and paper-reduction tools such as Microsoft Outlook Public Folders and single pass scanners• Performed interim network maintenance of Microsoft Server 2003 and Exchange 2003 including adding and removing printers, users, and computers

• Reviewed clinical data for subjects enrolled in large international trials• Reconciliation of electronic CRF (eCRF) data with central laboratory and central ECG data• Generation and tracking of queries (Data Clarification Forms)• Coding of medical terminology for clinical databases• Correction of clinical databases in accordance with edit specifications and in response to query replies• Quality control review of critical variables and query resolution• Execution of data validation programs and reports to facilitate data review• Trained other data coordinators as needed