Coach individual Global Study Managers as an expert in Project and Risk ManagementAdvised team on inter-department coordination for efficient sample management and testingBuild client relationships to grow the business portfolio and establish collaborative engagementReview and Present study metrics identifying areas for growth and improvement within the project portfolioCoordinate with Quality Affairs and Medical Affairs to maintain study compliance within global regulatory policy including GLP, GCP, CAP, CLIA, NYS, IVDR, HGRACRepresent Project Management for bid defense sales and identify project design for successful deliveryDrive Audit Delivery and resolution of findings including implementation of corrective and preventative ActionsDeveloped Tools for navigating study management output between lab departmentsConsult on SOW, Contract, and MSA terms with key client relationships

Consult on study timing with analytical method development and downstream clinical deliverablesManage the development of ADA, PK, and nAb analytical methodsManagement of Clinical Trials ranging from preclinical to post-market, including all phases I, II, III and IV of clinical trialsClinical trial experience in oncology, infectious disease, and rare diseasesReview clinical protocol and establish and monitor plan for analytical testing to hit major study deliverables.Highly Proficient at interpreting clinical protocols and applying trial needs to sample collection, logistics, laboratory testing, and reportingVersed in GCP, GLP, and CLIA regulatory management.Training and experience with ALCOA-Plus data integrity managementEnforce behavior to identify and correct CAPAs/QEs leading to process improvement. This includes the use of internal tools to analyze data/metrics to identify key points in process failureCentral contact and coordinator for all inter and intra-team interactions including external meetings with clients, vendors, or other departmentsResponsible for driving deliverables and deadlines, monitoring projects from contract initiation to archivingDrive data reconciliation between analytical lab, central lab, and study data manager Draft and manage individual project plans for unique sponsor contracts monitoring KPIs, metrics, and overall global portfolio.Manage contract budget scope changes and overall budgetAddress studies actions and documentation as required to keep the project properly documented and within regulatory standards

Draft and Negotiate Statement of Work and Service Agreement for ClientNegotiate bill rates for Statement of WorkStrategize laboratory labor needs for seasonal sample deliveryIdentify and Develop Team member growth opportunityAudit usage and billings for clients every weekAudit weekly team member time clock inputsDesigned and implemented a structured training program for seasonal talentCoordinate labor orders with remote recruiting teams via SalesforceDesigned Excel report to generate usage data into report dashboard

Data Collection, Data Management, Classroom Instruction, Laboratory Instruction, Laboratory training, Undergraduate mentor,

Cleaning Dishes, Isolating DNA, maintaining mouse colonies, PCR