Corporate enterprise portfolio management within the Center of Excellence leading the intake and discovery objectives for internal project ecosystems. Comprehensive project approval managing ideation/intake, discovery, triage accelerated discovery, prioritization, and business case development. Ensure robust end to end lifecycle governance, inclusive of program health reviews & reporting. Execution status, KPIs, benefits, costs, adoption, benefit/ROI realization and risk management.

Accountable for the end-to-end study start up and the designated system and process owner for SSU considering the big picture business objectives identifying process improvements and harmonization across system functionality, organizational design, and operating models.Partnering with business teams, clients, and IT to find the best way to design new processes and solve process-related problems mapping existing processes and designing improved ones using business process reengineering to analyze business processes and workflows with the objective of finding out how they can be improved or automated. Accountable for SSU operational improvement initiatives including:• Managing process change• Leading process redesign workshops• Educating business users responsible for managing and operating business processes• Monitoring, measuring, and providing feedback on process performance• Facilitating process workshops that involve eliciting process requirements and liaising with users• Applying their knowledge to documenting processes• Problem solving with a sense of urgency

The SSU Portfolio Strategy Leader provides oversight and surveillance for the delivery of start-up for a given portfolio of studies under a Client Delivery Unit (Enterprise and/or Biotech). The SSU Portfolio Strategy Leader is accountable for active surveillance, adherence to Client targets and status reporting for all studies in start-up under their Delivery Unit, and will be the main point of contact for their assigned Delivery Unit. The SSU Portfolio Strategy Leader will proactively liaise with the Critical Path Managers and collaborate with project teams, providing global study start up expertise to meet client expectations; and as needed restore client satisfaction through proactive communication & strategic solution-based approaches.

• Subject Matter Expert on clinical trial strategy development, study mobilization, study start up and trusted advisor on strategic planning across all operational functions ensuring translation of the risk-based strategy from the proposal into the operational plans. Ensures integration & coordination of the operational plans (such that all are driving to the same goals/milestones); reviews pre-identified risks & consults on supplemental risk and mitigation tactics; and ensures the team is fully prepared for the client KOM throughout the start up to successful site activation.• Provides oversight and surveillance for the delivery of start-up for a given portfolio of studies under the Enterprise Client Delivery Unit and directs the activities of Critical Path Managers to assure compliance with established partnership/client requirements or best practices serving as the main point of contact for the Client Delivery Unit Head.• Accountable for active surveillance, adherence to Client targets and status reporting all studies under the remit of the Delivery Unit.• Provide oversight to the project teams, providing global study start up expertise; including, study program lead (ie, Sponsor asset development), enterprise partnership process expert, feasibility, site identification/selection, management of the critical path, site activation advisement and consultation to mitigate study start timeline risks. Maintain and/or restore client satisfaction through proactive communication & strategic solution-based approaches to meet client expectations.

• Provide oversight and advise with project teams, providing global study start up expertise; including partnership knowledge, feasibility, site identification/selection, activation advisement and consultation to mitigate study start timeline risks• Review the proposal/contract, advises on strategic planning across all operational functions, ensures translation of the risk-based strategy from the proposal into the operational plans, ensuring integration & coordination of the operational plans (such that all are driving to the same goals/milestones); reviews pre-identified risks & consults on supplemental risk and mitigation tactics; ensures team is fully prepared for the client KOM and ready for study launch. • Monitor study progress and engage with teams as needed to advise & develop course-correcting strategies and critical path risk-mitigation tactics.

Experienced program and feasibility manager well versed in the development life cycle of clinical trials and operational deliverables with a strong background in project management, feasibility analysis, modeling, process engineering development and disciplines and program/clinical trial management systems with 14 years of clinical experience. The senior functional lead assigned as part of the core project team responsible to drive all feasibility and site identification activities immediately after award on all types and phases of studies including programs. The Sr. CFL is responsible to deliver an optimized operational strategy, based on selection of countries and clinical sites best positioned to successfully execute the trial/program. Through in-depth review of protocol design, competing landscape, and recruitment benchmark data, conduct initial protocol feasibility assessment. Conduct initial country selection analysis and deliver protocol-specific country recommendations including solid data-driven rational. Independently manage or guide CFS in managing country clinical operations survey including development of the protocol-specific questionnaire, collection and review of country data, follow-up discussions with local clinical operations representative, and compilation of collected information into country selection analysis, scenario modeling, and site identification strategy. Lead the development of an integrated operational strategy to successfully recruit patients for clinical trials and deliver enrolment scenarios aligned to the agreed strategy. Articulate and defend the proposed country and site selection strategy and enrolment scenario models in PAREXEL internal meetings and Sponsor meetings as well as present PAREXEL feasibility approach and processes in Sponsor capability meetings or audits.

• In collaboration with Medical Research and Clinical Trial Operations, successfully developed and implemented the global enrollment strategy for multiple programs which resulted in optimal country selection which reduced study feasibility cycle times.• Responsible for the protocol feasibility life cycle the studies in the Primary Care BU providing critical analysis from early modeling based on historical performance analysis, through to the actual final country recommendations and selection as documented in the Protocol Operations Plan providing faster more accurate data driven planning for the programs.• SME on the DVSO system; supported requirements development, UAT, world-wide training, and implementation. Performed enrollment modeling, built 100+ study plans and monitored progress performing risk mitigation and making recommendations to ensure teams meet and exceed established targets and objectives.• Pfizer Business Lead for the DVSO Resource Utilization work stream; managing assignments and GFM workload, developed the algorithm for continued support, collected and analyzed data developing the ROI metrics, and created the resulting Case Study process to document the outliers to the process.

• With Wyeth, was core member of Clinical Trial Operations and Management team responsible for delivering the design, development and drive the implementation of the Decision View Study Optimizer application.• Chaired the Wyeth Site Excellence sub team for Knowledge Management delivering the framework design for the Global Integrated Investigator View.• Managed the Clinical Study Enrollment Application, including updating the SQL, providing study teams a profile of compound, indication, trial, region and site performance data providing an evidence-based approach to evaluating sites, countries and regions ensuring better planning and more predictable performance.• Lead the Wyeth team that successfully piloted the Central Site Identification process for two large programs achieving the goal to increase the median number of enrolled patients per site and reduced percentage of non-enrolling sites.• Created the Executive Summary Dashboard reporting key study start metrics to senior management• Key member of the Pfizer-Wyeth Feasibility Process Harmonization team providing expertise regarding process, systems, and structure.

• Provided leadership to my team and operationally responsible for trial performance, analysis and metric reporting including but not limited to document durations, approval tracking, monitoring schedules, trip report process, projected vs. actual subject enrollment metrics, subject visit payments, initial CRF collection data and revenue recognition.• Provide operations management of the investigator database to ensure investigator data elements (contact/location data, enrollment metrics, specialty and experience characteristics, and other query elements) are current.• Responsible for the day to day management of the web CTMS system providing support to all users (internal, client, site, vendor), help desk troubleshooting/issue resolution, and monthly operating reporting. • Developed the business requirements for web based system, supported the design, development, validation testing and implementation. Provide trial set up, assignment management, and analysis for multiple systems (call tracking, clinical trial management, timekeeping system, electronic filing cabinet security/fire wall, and web portal).• Successfully performed global project team training on the software applications along with the SOPs. • Responsible for global enrollment planning and performance, feasibility process, investigator selection process, data collection and analysis of Investigator/Site metric data points and timelines.• Coordinate with the Chief Medical Officer and staff to develop the country feasibility survey along with goals and plans for site selection. Status and report on progress through the Investigator Database metric program.• 2005 winner of CEO’s Global OmniAward for outstanding-exceptional performance

• Managed the Institutional SI Program Management Office focusing on financial reporting, communications, and metric analysis for the Y2K rollover.• Created cost reporting by project that provided better control of project spending and metrics providing variance analysis resulting in improved estimation for future projects and business planning.• Instituted the Monthly Operating Review reporting all metrics to senior management including system service levels, financial analysis, staffing projections, testing results, diversity statistics, and project status.• Delivered the Institutional SI portion of the following communications, Board of Director’s book, Business Plan, Quarterly Reviews, and Divisional Meetings

• Executed program control performing all financial analysis and reporting including, cost and schedule performance measurement, billing, margin analysis, A/R, A/P, long range planning, and presented project status to upper level management. • Implemented an Earned Value System and chaired the Program Performance Reviews after developing the requirements for the cost collection system, and project control procedures resulting in improved reporting and more insightful management reviews.• Lead many cost proposal teams and key member of the winning negotiation team in Washington, D.C.• Implemented an integrated cost and schedule system to increase monthly reporting efficiency. Developed procedures to increase productivity and decrease engineering management time that was allocated to performance measurement which enabled the engineering team to focus on technical issues.• Key member of the Vice President’s Cash Tiger Team and received several awards for significantly improving cash flow.• DoD security clearances