Diane Campbell Email and Phone Number

Client facing advocate across digital technologies utilizing web portals (Medical Imaging [MI], Interactive Response Technology [IRT], Electronic Data Capture [EDC], (Regulatory Information Management [RIM], and Clinical Trial Management System [CTMS]). Managed a mixed portfolio of Top 10 Pharma, Mid-sized, and Biotech clients comprised of 150+ projects with a value in excess of $34M. Exceeded influenced sales goals by 200%. Successfully developed and implemented Success Plans, including RTG (Return to Green) plans resulting in new business sales. Mentored new CSMs and developed best practices for the global team.• Conducted NPS (Net Promoter Score) and CSAT (project level surveys) as part of Voice of Customer, setting the stage for multi-year, successful vendor refreshes and RFPs.• Used Gainsight Data Analytics to drive account planning and identify areas for operational improvement (aging cases, invoices, project milestones and RAG status reviews).

Primary interface between sponsors/CROs (Clinical Research Organizations) and Calyx internal teams. Responsible for 13 projects. Independently managed complex trials within 3 months, without prior IRT experience. Project management experience spanned the entire project lifecycle: RFP/Bid Defense, requirement specifications, UAT, live management (change requests), and closure. Provided Account Management, led governance, tracked and reported enterprise account KPIs.• Primary delegate for the Associate Director for a team of 8. Supervised one direct report.• Interviewed/mentored new hires. • Developed a Best In Class Project Management program for new/existing PMs.**Calyx split from Parexel in January 2021.

Owned a global EDMS (Electronic Document Management System) system. Initiated Data Governance for global registration, the foundation for a future IDMP (Identification of Medicinal Products) system. Served on the integration team for global regulatory affairs between Baxalta and Shire.• Completed a stalled project that removed a labeling compliance backlog. • Consulted on User Requirement and Configuration Specifications for a new, EDMS.• Directed a global project to upgrade and integrate 200+ SharePoint sites as part of the acquisition, leading to successful internal collaboration. • Supervised two direct reports.

Managed daily, global operations for RIM including FirstDoc, Publishing, SharePoint, Advertising & Promotion (AdProm) and other products and services. • Led business review for major Submission Management and Publishing system upgrades.• Tested and analyzed global regulatory systems ensuring a successful Day 1 split from Baxter.• Served on the TSA (Transition Services) team and oversaw rolling onboarding (2015-2017) of regulatory systems for 75 deferred country closings from corporate split between Baxter, Baxalta, and Shire.• Served as a Subject Matter Expert, Data Governance Lead, and Change Agent for development and implementation of a global Product Registration system (Veeva RIM).

Managed daily operations for FirstDoc Submission Document Management System. Integrated a $4 billion acquisition (Gambro) into Regulatory Information Management systems including FirstDoc, Product Data, and Advertising & Promotional Review software.

Supported regulatory submissions for commercialized and developmental products. Developed and executed a strategy to eliminate a significant backlog of FDA correspondences, thereby removing a compliance risk.

Serve as a liaison between business users and Information Technology.Develop and maintain strong working relationships with partner business units.Document business processes to develop business and functional requirements based on process workflow analysis, interviews, and experience.Participate in usability testing of prototypes and completed user interfaces.Develop and execute User Acceptance (UAT), Regression, and Cycle Testing scripts.Draft Regression and UAT scripts.Produce training guides and videos.Assist in the development of implementation plans and rollout of completed components.Build queries in Oracle Browser and SQL Developer to analyze data.