Amanda Wise Email and Phone Number
A multi-study, global reach, senior project team leader with clinical research and trial management experience from study start-up through close-out. Extensive experience with Phase 1-3 studies on a global scale, and experience with Phase 4/Real world studies. Highly dependable with strong analytical and problem solving abilities while being able to maintain timelines, budgets, resolve problems/conflicts and present high quality outcomes. Displays leadership by mentoring new CPMs and helping them gain new skills and grow comfortable in their role as not only CPM, but as an embedded FSP.Displays the following attributes:- Almost 10 years of Clinical Project Management- 12 years prior clinical research experience in bioanalytical/R&D space- Within management of Phase I -IV clinical trials: Act as a single, authoritative source of study information and lead study-level status reporting per organizational norms and expectations- Executed BLA submissions for 2 target drug trials which received accelerated approvals- Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and be accountable for effective study team operations- Lead study operational and functional teams through associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets and quality targets to meet or exceed business needs- Accountable for strategic planning and decision making at the study-level in line with program objectives- Experience as full service provider at CRO for 6 years, and an FSP for 4 with a client-embedded model- Lead cross functional sub teams and provide updates to governance teams as the accountable party for delivery and overall operational strategy of the trialSpecialties: Project Management skills like budget and revenue building skills over various studies and indications, 10 years of team mentorship, and 12 years experience in analytical laboratories for R&D and clinical trials that aides with leading and understanding research team needs.experience with RAVE, 4G, ePRO/PRO, BICR, CTMS, eTMF, EDC, VeeVa Vaults, and VeevVa EDC, GCP/GMP/GLP, Plansiware, StudyOptimizer, Microsoft Project, Excel, Word, PPT
Propharma
View- Website:
- propharmagroup.com
- Employees:
- 853
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Senior Clinical Project ManagerPropharma Nov 2024 - Present -
Sr Clinical Project Manager - Fsp, OncologyExecupharm Nov 2023 - Nov 2024 -
Fsp Clinical Project Manager, OncologyExecupharm Nov 2021 - Nov 2023 -
Senior Clinical Project ManagerIqvia Apr 2021 - Oct 2021 -
Project Manager IiPra Health Sciences Apr 2020 - Apr 2021Lenexa, Kansas, United StatesLeads meetings with sponsor and operations teams to facilitate project completion.Deliver the project within agreed upon timeline and budget, communicating with internal teams and the sponsor when out of scope work may be required.Provide notification of milestone completions for billing to financePrimary client communication focal point for project team for bioanalytical studiesWork as primary point of contact between PRA Clinic and PRA Bioanalytical Lab when the study is a "One PRA" contractTrain other PM’s and support staff within the group Part of the Innovative teams working to update internal LIMS and LES systemsAttend Bid Defenses as required and communicate with potential sponsors and current sponsors about future pipelines or assets. -
Project Manager IPra Health Sciences May 2016 - Apr 2020Lenexa, KsStudy Director and/or Principle Investigator over Large Molecule and Flow Cytometry in the Bioanalytical Lab for studies ranging from pre-clinical to late phase clinical. I work with several dozen Pharmaceutical and Biotechnology companies to plan, design and execute projects in both pre-clinical and clinical phases. The client therapeutics we are currently evaluating range target Alzheimer's, schizophrenia, specific cancer therapeutics, immune diseases (SLE and crohns disease), Gastrointestinal (Celiac, inflammatory diseases) and more.PRA’s North American Bioanalytical Laboratory in Lenexa provides small and large molecule analytical capabilities for pre-clinical and Phase I-IV trials and is fully harmonized with the Assen laboratory, therefore adhering to the same stringent guidelines.PRA’s Bioanalytical Laboratories: Service Offerings in Europe & North America• Mass Spectrometry;• Ultra / High Performance Liquid Chromatography;• Ligand Binding Assays;• Biochemistry (stimulation assays, enzymatic activity);• PK analysis of Small Molecules;• PK/PD/Biomarkers analysis of Large Molecules;• Immunogenicity (ADA) analysis (from Q4 – 2014 also neutralizing antibody measurement);• Flow Cytometry Unit;• Pharmaceutical Analysis;• Biohazard Laboratory with a Bio-Safety Level II (ML-II), qualified to handle samples potentially infected with, amongst others, HEP B, HIV and mycobacterium tuberculosis. Analysis of samples in the Biohazard Laboratory will be performed only when samples are Level II, or on specific Sponsor’s request. If samples are to be analyzed in the Biohazard Laboratory, it will be specified in this proposal. -
Adjunct ProfessorHighland Community College Dec 2014 - May 2016General Chemistry with lab, College Chem I and College Chem II (with labs)-Prepare Lesson Plans-Design lectures and innovative labs-Maintenance of lab supplies and equipment-Grading rubric and application -
Lab Manager/ Senior Research AssociateUniversity Of Kansas Medical Center Sep 2014 - Apr 2016Hematology And Transplant Research Group-Administrative duties: -Maintain grants of all 3 PIs -Purchase and stock all inventory-Mentor and train all junior scientists (graduate students, medical students, research assistants)-Design experiments with multi-step processing-Collaborate with other labs and institutes for matters of overlapping expertise-Writing/maintaining animal protocols-Data analysis and statistics-Cell Culture in 2D and 3D co-culture platforms-Harvesting primary cells from patient samples (peripheral blood or bone marrow)Western blots-Plasmid growth and purification-Transfection-Flow Cytometry -Animal work-Hyperbaric Oxygen studies-Clinical Studies-ELISA -
Quality Control AnalystSafc Mar 2012 - Oct 2014LenexaI worked with the Analytical and Raw Material teams testing both finished products and raw materials with a range of analytical chemistry tools. I performed moisture testing (Karl Fischer, LOD, ROI), purity assay titrations, species origination (ouchterlony) testing, HPLC amino identification, and bench chemistry to identify the product and impurities. Responsibilities- Site-wide coordination of the qualification/requalification testing program of raw materials for our formulations. - Meet Lead times for various client needs with raw material release- Work with client requests to identify issues with product in a timely fashion- Method Development for new raw material products (mostly for purity assays) - Member of the Raw Material Review Board - Bringing issues with material purity, biotoxicity, and other non-standard materials for discussion with an interdepartmental team- Collaboration with supply chain, purchasing project managers, R&D, QC, and QA plus other smaller groups- Method Transfer -
Graduate Research AssistantUniversity Of Kansas Aug 2010 - Dec 2011Lipid Biochemistry, under the mentorship of Alex Moise, PhD.Skills acquired:Insect Cell CultureAnimal Work:Tagging, Tail clipping and Genotyping, Maintaning the databaseProduction of LentivirusPlaque Assay Viral TitrationBaculovirus construction and infectionReal Time PCRHPLC - Agilent SystemFPLC - for protein purificationEnzymatic/Phospholipase Activity AssaysImmunoblottingIndependent experimental designAdipogenesis Differentiation, Oil Red-O stainingMentoring Undergraduate StudentsPresenting Data in a formal setting -
Research AssociateKu Medical Center Jan 2009 - Aug 2010under the direction of Faris Farassati, PhD, PharmD.Skills acquired:Cell CultureshRNA transduction Plasmid replicationWestern BlottingImmunoprecipitationAffinity assaysCell invasion assaysCancer stem cell sortingInvoicing/Purchases for the entire labSome grant writing experienceAnimal Care and Use Protocol writing experienceMentoring/Training the fellows and new technicians entering the labCoordinated the setup of the lab when we moved in 2009Creation of several data templates used for Data analysis.
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AssociateAptuit Apr 2008 - Nov 2008Bio-assay developmentSkills acquired: Cell culture maintenance (melanoma) Cell Based assay Client driven protocols -
Scientist IFort Dodge Animal Health Dec 2006 - Feb 2008Scientist I, In Vitro potency development under the direction of Thomas Hickey, PhDSkills acquired:Research and Development of ELISA AssaysOptimization of ELISA potencyOptimized ELISA testing under multiple antigen matricesData AnalyisisGLP data collection and processing (compliant with USDA and EU regulations)Handled direct contact with QC/QA on validated productsCell culture for antibody productionBiotinylation of antibodiesHigh proficiencies using relative potency programs, (eg RelPot, TableCurve, Sigma Plot) -
Lab AssistantIowa State University May 2005 - Jul 2006Entomology Lab under the direction of Dr. Matthew O'Neal, PhDSample collection and analysis of research materials relating to the increase of soybean aphids after pesticide application -
InternNew Links Genetics Jan 2006 - May 2006Lab intern under the direction of Marie Koenigsfeld, PhDSkills Acquired: Protein purification using columns Bacterial colonies: growth and manipulation Cell culture maintenance PCR Bradford Assays Making reagents, running DNA and protein gels, making buffers
Amanda Wise Education Details
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Pharmacology And Toxicology -
Pharmacology, Toxicology -
Ku Medical CenterPharmacology, Toxicology And Experimental Therapeutics -
Genetics -
Genetics
Frequently Asked Questions about Amanda Wise
What company does Amanda Wise work for?
Amanda Wise works for Propharma
What is Amanda Wise's role at the current company?
Amanda Wise's current role is Senior Clinical Project Manager - Oncology.
What schools did Amanda Wise attend?
Amanda Wise attended Michigan State University, The University Of Kansas, Ku Medical Center, Iowa State University, Iowa State University.
Who are Amanda Wise's colleagues?
Amanda Wise's colleagues are Linda Agasar, Christiane Garvey, Maryann Murray, Krishna Sree, Gayathri Sridharan, Celine Bianchi, Johannes B..
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Amanda Hunn
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Amanda Wise
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