Gina Risdall

Associate Director Clinical Operations @Arcus Biosciences

Minneapolis, MN, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Apr 2023 — Present

Associate Director Clinical Operations @Arcus Biosciences

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Provides strategic operational guidance to ensure trials are properly defined, planned, and executed across all clinical stage programs. • Contributes to the development of clinical asset life cycle and clinical development plans and establishes the operational plan for a new program or study including scenario planning, high level forecasting of timelines, assessment of program level feasibility, estimation of resources and budget based on internal/external benchmarks, and development of high-level operational strategies. Communicates initial budget, timelines, and changes to internal or external governance as appropriate. • Provides proactive innovative and flexible operational solutions and options for the CDP. • Participates in licensing/ partnership assessment as needed, providing strategic input as well as operational elements in terms of costs, resources, and timelines. • Accountable for meeting all operational deliverables in accordance with time, cost, and quality commitments. Maintains internal consistency across studies within a program and in alignment with functional standards across programs. • Contributes to asset management and program management across Disease Area Teams and/or Product Strategy Team as the Clinical Operations lead. • Provides program guidance to matrix teams within Clinical Operations by providing program specific guidance, clinical trial management expertise, operational strategies, and direction to achieve results. • Mentors and guides Clinical Operations staff. Provides timely feedback to functional managers regarding staffing needs and team member performance in the program. • May represent Operations or take a stakeholder role in company/function initiatives and regularly contribute to the optimization of existing as well as the development of new processes and resources. • Responsible for line management and career development of Clinical Operations staff (Clinical Program Managers, Clinical Trial Managers, etc.)

SKILLS

CRO ManagementEdcAssist in Preparation of Study MaterialsClinical Data ManagementU.s. Food and Drug Administration (Fda)Product DevelopmentIdeIso 9001GcpFdaClinical DevelopmentCapaEvaluate and Analyze DataClinical MonitoringQuality SystemResearchCROData CollectionCreate Source DocumentsHealthcareBiotechnologyIso 13485Good Clinical Practice (Gcp)Develop Improved ProcessesClinical ResearchLife SciencesProject ManagementCardiologyPmaR&DProtocolClinical TrialsRegulatory SubmissionsManaging Clinical Trials DataCross-Functional Team LeadershipCtmsLifesciencesMedical DevicesData Analysis

ABOUT GINA RISDALL

Experienced Associate Director of Clinical Operations with over 15 years in the…

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