Robert Nicholson Email & Phone Number

South San Francisco, California, United States

South San Francisco, California, United States

South San Francisco, California, United States

•Responsible for implementing and driving the success of the PDG Clinical Operations supplier management ecosystem through strategic sourcing, supplier performance management, continuous process improvements and supplier oversight. •Provided leadership and oversight while addressing operational and strategic opportunities and trends with Roche suppliers and managing performance and the relationship of suppliers supporting PDG clinical trials. (Labs, Clinical CROs and Technical Services suppliers).

South San Francisco, California, United States

•Partnered with procurement to govern and streamline the IxRS & eCOA landscape to establish standards, supplier performance metrics, issue escalation and CAPA resolution, and supplier relationship management•Developed and maintained an innovation roadmap for digital health solution, identified goals and quantified key opportunities to drive value, and aligned strategic objectives within the Pan-Roche/Genentech organization•Executed global initiatives, such as, eCOA system standardization, eTMF optimization, digital consent vendor sourcing, etc. through cross-functional collaboration & customer feedback to simplify trial execution•Facilitated Product Development Group (PDG) corporate goals to streamline systems implementation, end-user simplification, and pioneering new ways of working through digital health solution bundles, system risk assessments, and supplier governance.

San Francisco Bay Area

•Responsible for the overall satisfaction of key clients, working with those clients to determine and steer towards long term objectives, related to the design, development and support of interactive voice response systems (IVRS) for clinical trials•Serve as a point of escalation for all client complaints and issues, driving resolution and training staff to prevent future incidents•Work closely with project sponsors to understand business needs, both at the project level, and at the organizational level•Participate in bid defenses and other business development efforts to influence the decision-making of sponsors•Develop tools to assist project management staff with organizing and prioritizing their workload and managing their deliverables•Influence key decisions in the company, as a representative of client services in high-level cross functional discussions•Directly manage a team of employees, including senior project managers, project managers, associate project managers and project specialists, providing constructive criticism and mentoring to motivate and guide career development

San Francisco Bay Area

•Manage multiple (>10) complex projects concurrently through all phases, including budget, invoicing, staffing, project plan, and client deliverables. Experience in building systems with complex inventory (region specific kits, lab dependent titration), randomization (dynamic, adaptive design), and large scale (>50 countries, >5K subjects).•Coordinate with cross-functional teams in Client Services, Professional Services, and Technical Delivery resources to ensure the timely and quality preparation of project deliverables•Supervise team of Project Managers, Project Specialists, and Project Assistants to facilitate all project tasks, accountable for all team deliverables for key client accounts•Develop relationship with key client accounts and establish client standards for data and system builds. Participate in account management activities, business development scoping efforts, capability presentations and bid defenses•Manage direct reports at Project Manager and Project Specialist level. Responsibilities include training and on boarding process, coach, counsel, provide mentoring, ongoing career development, and performance feedback•Enhance the business model by institutionalizing business processes, implementing best practices and templates, and contributing to process improvement initiatives

San Francisco Bay Area

•Served as a single point of contact for clients throughout the system development, release, maintenance and closedown phases•Authored IXRS requirements document for all new systems and enhancements•Managed all internal and external deliverables, schedules and timelines for development, testing and data management teams with respect to system enhancements•Provided regular status reports and participated in regular conference calls with clients to document study progress and any issues/questions requiring attention•Generated internal reports to identify trends in data changes and tech support issues•Collaborated with software developers and test engineers to efficiently resolve system issues and conduct thorough enhancement design review and functional assessments

San Francisco Bay Area

•Supervised four high-paced clinical trials per ICH/GCP and regulatory compliance for Alzheimer’s Disease & Frontotemporal Dementia which enrolled & evaluated over 200 subjects•Provided lead project management and clinical monitoring activities for Forest Laboratories Inc., including site initiation, interim monitoring visits, trial master file maintenance and data review for an investigator initiated dementia study•Spearheaded budget negotiation and study initiation, completion, and submission for initial Institutional Review Board (IRB) approval and annual renewals for all five clinical trials •Prepared drug accountability, accurate study documentation (regulatory binders and subject source charts) and safeguarded readiness for interim monitoring and/or audits through data queries

San Francisco Bay Area

•Provided logistical support for operational activities; collected data and served as a liaison between department operating units in the resolution of day-to-day administrative and operational problems•Initiated and executed meetings, interviews, appointments, SIV and other similar activities for supervisors, which also included travel and lodging arrangements•Analyzed metrics and developed medical presentations with primary investigator at national medical conferences and performed extensive data collection and analysis using SPSS software