Analyzed and surved vendor database, dissect and input data into digestible reportsResearched compounds within the database, link to specific cancer targets and connect to the best Method of ActionCommunicated the research compound, present to CBO on rating level, indication, best MoA, and planned phaseCreated Excel documents to group the reports into metrics that C-suite can make knowledgeable decisionsCommunicated cross-functionally, worked close with Transitional Science team to identify compounds best suited with the companies current modelCreated PowerPoint slides for C-suite and Board presentation Worked closely with the Chief Business Officer, while provided solutions to any risks

Directed the technical, financial, and operational aspects of projects, securing the successful completion of clinical studiesProvided input for study specific plans, contracts/budgets, proposals, and other key study activitiesPartnered with cross-functional leads to identify project issues and risks, interprets data on complex issues, makes good business decisions and ensures solutions are implementedEnsured that all project deliverables meet the time/quality/cost expectations and financial performance targetsLead project team meetings (for assigned studies) and documents key decisions, actions, risks, mitigationsLead cross-functional coordination both internal and external, inclusive of sub-contractors Defined and managed project resource needs and establishes contingency plans for key resources Ensured successful design, implementation, tracking and revision of project plans, finances, risks, action items, and decisions for assigned projects Promoted effective teamwork among project team members; resolves conflicts as needed Ensured appropriate escalation within project team for key project risks and issuesInitiated improvements to enhance the efficiency and the quality of the work performed on assigned projects Acted as cross-functional escalation point of contact for assigned projectsEstablished excellent working relationships with project teams and vendors to ensure satisfaction and operational excellence

Managed cross functional project teams derived from the groups within clinical development to deliver a high-quality clinical trial(s) in compliance with all regulations and SOPsWorked with functional areas on initiating, planning, executing, controlling, closing and resourcing clinical trial projects. The CPM acts as an operational nexus or focal point for interdepartmental and intradepartmental groups (e.g. stats, data management, safety, manufacturing, regulatory, vendors), coordinating these different groups in a matrix environment to drive and complete clinical programsDrafted and reviewed protocol, source documents and CRFs and tracks them to completionCreated and maintained project timelines for each project and uses these timelines to track and manage a project’s progressCreated Project Plans (Roles and Responsibility Tables and Communication Plans) and weekly project budget and progress reviews for each studyReviewed study metrics for performance and quality with the team and managementPrepared high-quality reports (financial, project, etc.) for management on program status and issuesEnsured review of clinical electronic Trial Master File (eTMF) for completenessManaged and coordinated all vendors involved in the clinical trials (e.g. central labs, IVRS, reading centers)Other duties may be assigned

Assisted with developing and implementing clinical development plans, including clinical budgets, timelines, resources, critical milestones, etcWorked with Clinical Project Management to ensure periodic reporting of clinical program progress to clinical leadershipEscalated selected issues and mitigations to clinical project management leadership for decision makingRepresented Clinical Operations and Clinical Project Management function at various company decision-making bodies and possibly externally to key collaborator stakeholdersWorked collaboratively with Finance, Business Development, Research, Nonclinical Development, Regulatory, and Technical Operations, to plan and report clinical project progress and track clinical budgetFacilitated and managed productive team communication and collaboration, where indicated, both internally within Clinical (including Clinical Operations, Clinical Science, Data Management, etc.) and externally (agenda, minutes, follow-up on actions, etc.)Facilitated and provided feedback for bid defense meetingsLead monthly finance meetings for each study with project leaders to discuss financial state, AP/AR, and pending CO/POProvided program support for continuous improvement initiatives for the development of metrics against Time, Quality and Cost, e.g., Cost Modelling, Capacity Planning, and Resource ManagementProvided reports of current study finances, accruals and pending milestones for VP Clinical OperationsProvided feedback in regards to risk assessments, site selections, vendor selections and contract negotiations with VP of Clinical Operations, and Project LeadersProvided CRO finance Oversight, as well as cross-functional finance rolesProvided reports for oversight of 11 clinical trial studies, burn rate of Pos, reconciliation of past invoices and provide details for accruals/forecastOther duties may be assigned

Provided operational execution of assigned Clinical TrialsPerformed Global Clinical Trial Management. duties in vendor management of Parexel, LATAM regionCollaborated with GSML, Clinical development, Regulatory Affairs, Global Drug Safety, Clinical R&D, Global Clinical Supply, Procurement, Vendor Oversight and R&D Quality Assurance to ensure proper delivery of studiesExecuted ICF reviews, Recruitment plans, and other study related activitiesTasked with preparing, collecting and tracking master study level documents and site non-regulatory documents, producing reports on clinical status, trends and metrics and facilitating communication across Allergan departmentsTasked with study financial management, database lock activities, study enrollment management, vendor management and ensuring adverse event reportingProvided budget, forecasting, accruals per vendor and project managementOversight of contracts, change order, invoicing, addendum per vendor oversightCreated and maintained study trackers as well as various forms of charts and graphs to display study informationLead in accruals for monthly progress and reporting for studies. Involves maintain and management of accruals report and submission to the finance team. Putting together the studies of financial accruals, reviewing the details, and submitting them to the finance teamsCreated weekly reports for the POL. This consisted of creating PowerPoint presentations, maintaining metrics of all studies, draft graphs, reports and other various tables to execute study presentationLead in maintaining COVID-19 patients information, visit schedule, progress of sites for all studiesFacilitated meetings for both IMP status for LATAM region, COVID-19 related activities in regards to patient tracking as well as to ensure risks of decisions made by vendors to execute clinical trials on a timely mannerAdditional work includes vendor oversight

GAP Reason: On Mission Trip from Sep 2018 – Dec 2018 - in Uganda, South Africa; started to actively apply in Jan 2019

Assisted Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) in hematology/oncology therapeutic area with accurately updating and maintaining clinical systems that track site compliance and performance within project timelinesAssisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating proceduresAssisted with periodic review of study files for accuracy and completenessAssisted CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking informationAssisted with the tracking and management of Case Report Forms (CRFs) through eTMF/eClinical, queries and clinical data flowAssisted with tracking ISF/IPIM regulatory binders, IP(Investigational Product – Drug) supplies to site to make sure they are monitored with the CRAActed as a central contact for the clinical team for designated project communications, correspondence and associated documentationExecuted ICF reviews of both Central and Local site(s), submission to Advarra(Chesapeake/Shulman via CIRBI portal), eConsent experiencePerformed assigned administrative tasks to support team members with clinical trial executionElectronically filed documents per code onto eTMF (Veeva Vault – Electronic trial master file) for audit and close-out processCorresponded with Site: Study Coordinators, Research Coordinators, etc. to keep each site on track with phases of researchCorresponded with DFM (Development Feasibility MGR.) and RCTM(Regional Clinical Trial MGR) during each phase of the studyExecuted feasibility coordination of new sites, review site information and check Primary Investigator’s department status, and setup site contact listInitiated Start-up Site, including documents, site contact, and other information regarding site registrationOther duties as assigned by the Line Manager

Aided in writing, formatting and subsequent processing of documents(SOPs, MPs, RMS, Labeling) related to the implementation of products into QMSWrote/updated procedures by using template/feedback provided by Senior department Associates(R&D, Quality, Operations)Initiated required forms to process the documents through an electronic/paper-based document management systemManaged release of documents and control of updates to documentsManaged documentation via Excel(Macros and Pivot Tables) for QAWorked with cross-functional team, as well as unsupervised to execute projectsAttended meetings, updated on progress and gave input on solutions to work as a team Assisted directly to Regulatory Specialist IPrepared documents for ISO AuditQA’d FDA documents as well as Consent Forms(CRF)Provided control distribution of new releases and recall/destruction of obsolete documents Other duties as assigned by the supervisor

I was responsible for maintenance and quality control of paper documentsElectronically filed documents into LIMS system and archived documents per SOPsAdhered to ISO/IEC 17025, cGLP, SOPs and CLIA protocols I was tasked to calibrate scales, pipettes and other instrumentsPrepared samples for dilution in preparation to be testedI was tasked to maintain laboratory records, update logbooks and adhere to ISO standardsTrained new lab techniciansVarious other duties as assigned by the supervisor

Project management: from $1,000 to $300,000 size jobs. Day to day management. This included coordinating projects, risk and budget control, and estimating to show profit in every job.Customer service: I personally followed up with customers diligently, showed patience with strong communication skills.Installation: I executed hands-on skilled work as well as oversaw tasks and projects. Constantly studied the industry to upkeep with all the new products, understood scopes and utilized in future projects. Networking: I was able to build a customer database through integrity and excellence in products. Strong communicator. I applied myself to many business networking organizations, such as BNI and Chamber of Commerce. Maintained invoicing, employee project reports, job completion sheets, and error accountability. Showed strong organizational skills towards employees, projects, and tasks. I also prepared for all future audits. Problem solving: I was able to rectify problems in a stressful environment, with honesty and holding true to the reputation of the business.Sales: I was able to turn profit during recession and was able to keep from 4 to 14 employees on payroll. Profit fluctuated from $400,000 to $600,000 in yearly sales.Interviewed/Trained up new employees with no prior glazing experience. I was able to present, promote and teach men and women to grow in the company as valuable assets, as well in the industry.I held bi-weekly meetings to motivate by setting goals, encouraged with rewards and micro-managed tasks as a servant leader. I also maintained and tracked minutes, and monitored teams.

Executed tasks requested by managers from customer service, sales, delivery and pick-up equipment,to data entry.