I was accountable for the successful implementation of a master data management solution to be built upon across the enterprise, through the local PMO, including the coordination of data governance, SFDC, vendor, Boomi and legacy software teams  Establish project plans with associated milestones and deadlines Communicate with staff and external vendors throughout projects  Coordinate creation, routing, tracking, and archiving of project documentation Accountable for vendor management and deliverables, including services, and licensing Laid out OCM plans for MDM project

Needed to take a break to care for my maternal grandparents and that situation is now resolved. Continued sharpening my skills in time management, budgeting, scheduling, decision-making, and project management during this career break. Excited to re-enter the workforce and utilize my skills and experience in the pharmaceutical industry.

Short term contract providing services to Roche DiagnosticsI was accountable for the successful implementation technical solutions across the enterprise, including customer contacts data governance, legacy software replacement for order fulfillment, and proof of concept application for increasing lab assessment efficiency.  Establish project plans with associated milestones and deadlines Communicate with staff and external vendors throughout projects  Coordinate routing, tracking, and archiving of project documentation Accountable for vendor management and deliverables, including services, licensing, payments, invoicing, and vendor management activities.

Short-term contract providing services to Signant HealthI facilitated the implementation of electronic clinical outcomes assessments (eCOA), and electronic patient reported outcomes (ePRO) for client clinical trials Establish project plans with associated milestones and deadlines Communicate with staff and external vendors throughout projects  Coordinate routing, tracking, and archiving of project documentation Responsible for day-to-day management of direct reports including the personal development and performance management activities Handle client escalations independently and work with internal and client teams to resolve these. Escalate as appropriate in a timely manner. Accountable for vendor management and deliverables. This can include services, licensing, payments, invoicing, and vendor management activities.

I facilitated the development of a 510K Catheter Drainage device and an Angiographic Catheter device Developed tracking and analytics via custom dashboards and available PM tools, such as MS Project, SharePoint, and Project Central Establish project plans with associated milestones and deadlines Communicate with staff and external vendors throughout projects  Coordinate routing, tracking and archiving of project documentation Collect and document project risks and issues Provide coaching and guidance to team leaders in best project practices

I facilitated assigned projects and programs via custom analytics dashboards and various PM tools, such as Jira, SFDC and ProchainDeveloped a portfolio management process for an enterprise solutions groupFacilitated an enterprise wide development and implementation of Amazon Web Services (AWS), including necessary processes and reporting for Scrum based programCreated a portfolio management dashboard and database to track assays, cradle to grave, for clinical trials on behalf of a scientific discovery department

Facilitated a national, cross-functional project to upgrade the software of approximately 475 medical devices within 8 months for Roche Diagnostics.Provided project clarity to core team and extended field team via near real-time dashboard

Managed local implementation of global big data strategies.Provided coaching/mentoring to others on project management principles and techniques. Provided direction on big data issues to assist Roche Medical and Scientific Affairs leadership in setting strategic direction.Managed the tracking and reporting of project success measures. Provided feedback to the organization (such as project risks, deviations, potential corrective actions) to assist with resource allocation and developing corrective actions.Developed SharePoint site for Medical and Scientific Affairs department

Managed global supply chain for clinical project kits provided to client investigator sitesServed as primary point of contact for client contacts, supply chain vendors and internal stakeholders for kit projectsCreated kit proposals (RFP), budget estimates, integrated project plans, kit support materials for client project, import/export documentation, investigator manual, requisition pages, vendor contracts and internal project documentation Provided training to sites for sample collection, packaging and shipping on a global basisFacilitated client meetings in support of clinical projects Monitored and resolved issues on projects; budget, supply chain, sample management, or other commercial concernsIdentified other services that the client may need for the project and provide information for buy-upsProvided coaching and developmental opportunities to internal team members on projects

Primary point of contact for supply chain vendors, CROs, investigator sites and internal stakeholdersProvide quarterly comparison of PM deliverable dates to the capacity planner effort datesProvided guidance on monthly reports for budget monitoring, quarterly forecast & business plan reportsDeveloped integrated project plans, risk management plan, budget and resource estimation, metric reports; milestones, capacity models, and GAP analysisSubject matter expert for change control process, create change control slide deck for governance, and SAP reports to validate processDeveloped and maintained project schedules, work break down structures in MS Project and SharepointManaged critical path and leading indicators of the team’s progress to major milestonesLead the clinical team in implementing clinical trial protocol, informed consent document and final study report Partnered with Data Management/IT to assist with Case Report Form design and data collectionEnsured that the team plan and the business plan budgets were aligned and communicated to the team the cost of development options and drove reforecast when necessaryDocumented key decisions, actions and key modifications in scope, resources and timeline. Archived all relevant team information at the termination of a projectCoordinated the creation of integrated drug development plans or subsets that translates the “label as driver” strategy into operational objectives

Primary point of contact for supply chain vendors, CROs, investigator sites and internal stakeholdersDeveloped medical narratives process and training materials e-data capture studiesCreated, revised and updated both platform and protocol level Project Management Excellence (PME) documents for Abilify unipolar depression programLead study team to organize safety updates and three study report filings for Abilify programOrganize, manage and update information management system; Partner Collaboration System (PCS); web-portal for unipolar depression platform Maintained clinical trial information management system for Abilify and Medarex platforms–IMPACT/CT-ManInvolved with request for proposal process (RFP) – CRO, Central Lab, Imaging and IVRS vendorsPlanned and Conducted Vendor Kickoff and start-up meetings for Medarex platform

Developed protocol risk management plan, budget and resource estimates, metric reports; milestones and GAP analysesLiaison with Contracts for negotiation with investigator sites and vendors, performing request for proposal (RFP) process with CRO, central lab, imaging and IVRS vendorsDeveloped best practices and streamlining strategies for global implementation Developed and implement trial monitoring plan, including enrollment strategies with Clinical Research Associates (CRA) and study coordinators, Prepared one page patient summaries and Serious Adverse Event (SAE) reportsLiaison with clinical team to prepare final study reportPartnered with clinical team to draft and implement clinical trial protocol, CT material plan, informed consent document design and final study report designManaged and maintained protocol milestones and metrics in CTMS database

Primary point of contact for client contacts, supply chain vendors and internal stakeholdersResponsible for managing phase II to IV clinical trials spanning the globeReviewed clinical protocols to gather information and requirements to write Statement of Work (SOW) for new studiesDeveloped kit support materials for client project; import/export documentation, investigator manual, requisition pages, and internal project documentation Provided training to sites for sample collection, packaging and shipping on a global basisCo-developed kit specifications to meet data collection requirements for client Facilitated or participate in client meetings in support of projects Coordinated project at all stages with Sponsors, investigator sites, referral laboratories and internal departmentsMonitored and reported status of recruitment, kit supply utilization, sample management, patient's progress, lab resulting and budget forecast to actual

Managed twenty non-testing personnel and day-to-day workflow for Microbiology Processing DepartmentWrote and conducted performance reviews and interviewed candidatesTracked performance metrics via monthly reports and established departmental standardsTrained staff in departmental procedures and specimen management softwareProvided support for Technical Liaisons, Quality Assurance, and Project Teams by resolving issues ranging from discrepant results and special testing, to changes with specimen shipping and change controlsCreated and updated specimen management database for Microbiology specimen storage