Jeff Reyes Email and Phone Number

Added responsibility to support DM Operations process/project management and inspection readiness.

Added responsibility to manage cross-functional processes.

Accountable for the management of Specialty Program Leads as they ensure the completion of assigned study timelines and deliverables with the study start up, conduct and closure of clinical studies in the Specialty Therapeutic Area (Virology, Anti-infective, Gastroenterology, Women's Health, and General Medicine).• Business Process Transformation Lead (BPTL) for Data Management Operations - Collaborate in the project management, integration, and/or implementation/change management of new and enhanced business processes and applications in the CDSO DM space.• Program Co-Lead in the development and implementation of the Database Lock Improvement Initiative.• Data Management Liaison in the implementation and deployment of Veeva Vault EDC including business process documentation. • Recruit and onboard Program Lead resources with the proper training and the collaboration with clinical study matrix team members as well as the functional service provider resources in the execution of clinical data management activities per business processes.• Oversee that the clinical studies are conducted with data quality, integrity and compliance where any deviations are properly documented for traceability and audit readiness.• Ensure proper Specialty status reporting to DSS and CDSO Leadership as well as cross-functional partners.• Support DSS and CDSO Leadership with any business and/or technical requests as needed.

Former Head of R&D IT (IMMU) responsible as technical liaison to Clinical R&D Oncology for Trodelvy™ (Clinical Development, Clinical Data Management, Biostatistics/Stat Programming, Clinical Operations, Safety/PV, Regulatory Affairs, Medical Affairs, Pre-Clinical and Research) including GCP business processes and computer system validation with IT strategy and technology solutions focusing on the Veeva Vault unified platform as applicable. Transitioning to Gilead R&D IT Clinical Capability/Product Director.• Led the R&D IT system integration workstreams and completed the decommissioning under the Gilead Integration Management Office (IMO) regarding financial management, contracts assessment, software licensing/maintenance, process-technology discovery, application disposition, business rationalization, project planning, data migration, Part 11 compliance/validation and decommissioning for the Clinical R&D organization. Coordinated transition with FP&A, IT Security/Single Sign On, IT Helpdesk and Training/GxPLearn.• Program manager/technology lead and SME for business capabilities/needs, budget preparation, tool evaluation, vendor qualification and selection, MSA/SOW agreements, procurement process, invoice tracking, project team, user requirements, system validation, performance qualification/user acceptance testing, system implementation, access management, training, data migration and change management.• Oversaw strategy, implementation/upgrades and decommissioning of the Clinical R&D technology portfolio: Veeva Vault CDMS (EDC), Anju ClinPlus (EDC), Veeva Vault Clinical Operations (eTMF/CTMS), ICS JReview, SAS (LSAF/PC-SAS), Pinnacle 21 Enterprise, Accenture StartingPoint Templates, Veeva Vault RIM (Submissions/Submissions Archive), Ideagen PleaseReview authoring & review workflows, Lorenz docuBridge Publishing, Oracle Argus, PVQ Query Tool, MS-Teams and SharePoint. Managed and facilitated the budgeting, and procurement of the R&D Technology roadmap.

Reported to the Executive Director, CDM; supported and advised Clinical Data Management Operations (CDMO) leadership to develop and implement strategy in an agile hybrid operating model with functional service providers. Designed and implemented global business processes conforming to systems and standards and enabling compliance across multiple vendors in the CDM Transformation project.• Clinical Data Management Process and Technology SME • Proposed and developed strategic/logical approaches with planning, prioritization, and orchestration for CDMO process transformation (consolidating SOPs and streamlining Guidelines).• Performed program manager role for the upgrade, integration, and maintenance of the CDM operating model where clinical trial processes were modified with the addition of Syneos Health (formerly INC Research) CRO for Oncology to previously centralized Cognizant business processes.• Performed audit coordinator role for MedImmune CDM for internal AstraZeneca QA audits with a focus on ICH E6(R2) for clinical trial audit readiness including audit responses and CAPA remediation.• Analyzed and documented an enhanced external data CDMO process in collaboration with medical monitor and statistician for setup and collection including potential of handling unblinding data.• Facilitated the transition of SAE intake, reconciliation, and Medidata Rave-to-Oracle Argus data exchange processes from Patient Safety to Clinical in the AstraZeneca OnePS Project.

Reported to the Head of Technology Information Management (TIM); performed roles for program strategy (process, application, and business architecture), program/project management, agile development and implementation, business process re-engineering, work stream coordination, technology integration and transverse organizational convergence for TIM at Sanofi.• Assigned to the UNIFY project (Clinical R&D Integration of Sanofi Pharma, Sanofi Pasteur and Genzyme) working in Process Optimization and Automation-POnA, Trial Management-TM and Risk Based Monitoring-RBM workstreams developing capability maps, process improvement workflows, and RBM process-system implementation projects for pilot studies.

Reported to the VP, Clinical Informatics; developed and implemented Clinical Data Management and Biostatistics business process and technology workflows. • Data Management business process development and organization documentation. • Project Leader for rCDMS Implementation (near real-time incremental and integrated clinical trial database)• Project Leader for CTMS Gateway Implementation (support study initiation, study management, predictive modeling and analytics)

Reported to the VP, Clinical Informatics; developed and implemented Clinical Data Management and Biostatistics business process and technology workflows. • Planned, tested and integrated Mission3 OnDemand software (EDM and eTMF modules) with the Clinical Operations, Regulatory and QA team members.• Developed, planned and facilitated the DSG eCaseLink (EDC/IWRS) system validation with the project team.• Verified and tested the Investigator Payment Module under DSG eClinDirect (CTMS).• Developed business processes and flowcharts as needed.• Completed the validation of IWRS for automated subject randomization and study drug management.• Prepared scope statements and evaluated CTMS and DMS solutions for aligned fit to the organization.

Reported to the CMO; led Oncology Business IT vertical team directors supporting Clinical, Regulatory and Drug Safety departments for Erbitux™ and other mAb biologics in the pipeline. Facilitated the analysis, planning, implementation, support and training of business systems and processes. Extended services and support to cover Research at the New York office in August 2009. Performed business analysis, strategic planning, technology portfolio management, process mapping/SOPs, stakeholder reporting and relationship management.

Reported to the VP, Regulatory Affairs; led Regulatory Operations managers in planning, information assembly, submissions, records management, and regulatory systems. Core functions: departmental administration, regulatory compliance, global health authority audits, submissions management and quality review, process mapping/SOPs, regulatory systems management, clinicaltrials.gov registrations, and clinical document archives.

Reported to the Executive Director, Clinical Operations; led Clinical Systems managers in the analysis, planning, programming, implementation, support and training of Clinical Trial Operations business systems and processes. Core functions: departmental administration, regulatory and corporate compliance, process mapping/SOPs, global strategic planning and technology portfolio management, business analysis, project management, application programming, implementation/delivery, stakeholder reporting, relationship management, and application management.

• Performed project manager role and successfully implemented a Global Oracle Clinical Implementation project.• Provided system administration / DBA / programming / system validation support for Clintrial (clinical data management software), Oracle and SAS.• Performed data transmission tasks (import/export) with 3rd party vendors.

Led Clinical Data Management department that included clinical trial database development, edit check programming, data analysis, medical data coding and data entry groups.

Project manager for Clintrial 4 Implementation in the Clinical Data Management Reengineering (CDMR) Project

Led Clinical Data Management department that included data analysis, database development, SAS and SQL programming, medical data coding, dictionary management, software maintenance and gSOP/gSWP documentation.