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Click here or scroll down to respond to this candidateCandidate's Name , MSMcHenry, ILEmail: EMAIL AVAILABLE Phone: PHONE NUMBER AVAILABLEhttps://LINKEDIN LINK AVAILABLESummary of Experience:Pharmaceutical and clinical research professional with 25+ years of experience. 3+ years of experience as VP Clinical Affairs group overseeing all clinical management activities for an AI driven medical device company. Over 8 years within R&D from concept to launch. 18+ years of Clinical Research industry experience, 10+ years of Clinical Monitoring experience, 8+ years of Clinical Project Management experience (both US and International) overseeing all phases of clinical research trials with proven management and leadership skills while mentoring junior CRAs as well as all on-site monitoring activities for various clinical studies. Have successfully led and completed 12 Phase I studies, 11 Phase II studies, 7 Phase III studies, and 4 Phase IV clinical research studies with vendor management and oversight responsibilities. Have managed multiple, ongoing Phase I, II, and III trials covering the following therapeutic areas within Clinical Operations; Oncology (bladder, melanoma, non-small cell lung, prostate, liver, colon, breast), Cardiovascular, Bleeding Disorders, Pain Management, Depression, Diabetes, Infectious Diseases, Neurologic, Women's Health, and Alzheimer's. Extensive experience with Medidata RAVE, CTMS, iMedNet, Impact, Inform, and MS Project. In-depth knowledge of GCPs, ICH guidelines, and FDA regulations. Represented company and presented at on-site FDA meetings. Possess outstanding written/ oral communication skills and proven techniques to effectively manage several studies across multiple projects while maintaining clear communication lines with upper management reporting responsibility.Professional Experience:4/22-4/23 Kelly Services assigned to Janssen (J&J)Global Trial Leader, Medical Affairs- OncologyIndependently managed key Phase II global oncology trials with multiple sites reporting overall study management progress to leadership teamManagement oversight responsibility of CROs and external vendorsSuccessfully took over and seamlessly transitioned two key clinical trials from outgoing clinical manager without impact to project milestones.Collaborated with Sr. Managers to identify vendor selection, patient recruitment/ retention strategies, as well as site selection activities05/18-2/22 Laboratory for Advanced Medicine Inc., West Lafayette, INVP of Clinical AffairsProvide companywide strategic leadership to the Global Clinical Operations Team and work directly with the Chief Regulatory Officer to assist in leading all FDA Clinical Trial management efforts globally for successful launch of key Oncology FDA Clinical Trials including enhancements pipeline for various cancer research programs.Serve as lead contributor and direct interface with FDA alongside Chief Regulatory Officer representing the Clinical group at key submissions meetings with the FDA as well as CMS for reimbursement for the CompanyWork directly with Leadership Team (CEO, Chief Regulatory Officer, CMO, CTO, and CFO) to advance key initiatives, promote commercialization efforts, and manage all Clinical Affairs programs for the Company02/17 1/18 Advanced Clinical assigned to AllerganGlobal Clinical Management OperationsSr. Regional Site Manager IIIOversee and conduct research clinical trials/ monitoring for 26 key clinical sites throughout the US for Global Clinical Operations team maintaining global projects for a variety of therapeutic areas, such as IBD, FC, Neurologic disorders, Uterine Fibroids, and several Depression studies for both adult and pediatric populationsIndependently managed multiple sites for various clinical studies with monitoring responsibility from site qualification to site closeout visits and overall study management progressOverall responsibility for CROs/ vendors and all operational activities of the clinical studies, from start-up through monitoring for multiple therapeutic areas in a matrix environment.Successfully took over and seamlessly transitioned several sites from outgoing Sr. CRAs as well as all on-site monitoring activities for clinical studies without impact to project milestones.Collaborated with Sr. Managers to identify vendor selection, patient recruitment/ retention strategies, as well as site selection activities10/15 to 01/17 Real Staffing assigned to PfizerGlobal Established Pharmaceuticals- Clinical OperationsClinical Project Manager IIIProvided strategic leadership to the Global Clinical Operations/ Global Established Pharmaceuticals Management Group maintaining global projects, and enhancements pipeline for various clinical programs/ projectsIndependently managed multiple sites for various clinical studies with monitoring responsibility from pre-study visits to a site close out visitsOverall responsibility for CROs/ vendors/ US and OUS clinical site contracts and all operational activities of the clinical studies, from start-up, monitoring, through clinical study report (CSR) completion for multiple therapeutic areas in a matrix environment.Supervised in-house CRAs as well as all on-site monitoring activities for clinical studies.Served as the primary interface for vendor selection, patient recruitment/ retention strategies, as well as budget negotiations with outsourced vendors4/15 to 10/15 Baxter Healthcare Corporation Round Lake, ILMedical Products- Project Management OrganizationProject Manager, Premix Drugs and OncologyProvided business and technical leadership for several projects/ clinical studies under the Project Management Organization including planning and coordination of projectsUtilized MS Project to monitor, coordinate, and manage all research and clinical activities required to support the projects portfolio and maintenance of all premixed drugs and Oncology products for the divisionManaged and coordinated core meetings with key stakeholders by core/cross-functional teams to ensure continued on-time delivery of products while maintaining projected forecasts and future distribution plans for plantsAccountable for core team performance, project schedule and execution, budget commitments and spendLed core teams in defining project strategies, developing goals, and ensure project scope is defined and controlledContinuously interacted with all functions and levels of management ensuring effective ongoing communications across teams and stakeholdersEnsured identification and communication of project risks within the core teams and drove proactive management of risk response strategies8/14 to 3/152/14 - 8/145/13 - 2/144/12 - 4/137/10 - 4/12InVentiv Health Assigned to AbbVie Abbott Park, ILClinical Project ManagerAssisted Program Manager in planning, management, and execution of one or more clinical studiesAssisted with Management of CFO and vendors such as CROs, Central Lab, and other suppliersPerformed matrix management of functional area leads to meet study deliverablesCoordinated study activities such as study design, protocol preparation, investigator selection, investigator meetings, contract preparation, vendor selection, CRF design, as well as other clinical project activities to ensure on-time completion of studiesSupervised in-house CRAs as well as all on-site monitoring activities for clinical studiesIdentified, assessed, and successfully managed any critical site issues with potential impact on evaluable study data, ethical study conduct, and ICH compliance to ensure seamless study execution and on-time deliverables and milestones metEffectively communicated study information and escalation of issues to upper management teamProposed corrective action plans and contingency plansAssisted in development and management of the study and/or site budgets with Clinical Procurement Research Management teamQuintiles Corporation, McHenry, ILSenior CRA III, Global Clinical OperationsManagement responsibility of over 24 sites across multiple protocols within Neuromodulation studies for Parkinsons Disease, Headache Disorders, and Pain ManagementDirect mentoring and oversight responsibilities of junior CRA staffAbbott Molecular, Des Plaines, ILClinical Project Manager, Clinical AffairsOverall management responsibility for the key in vitro diagnostic clinical study projectsDesigned, implemented, and monitored clinical studies of new and modified in vitro diagnostic Products, for indication of NSCLC, Melanoma, and Bladder cancers, with all responsibilities including managing budgets, contracts, and vendorsEnsure that the clinical studies are conducted per established procedures, policies, GCPsParticipated in preparation of regulatory submissions and international registrationsManaged large, complex projects and/or several smaller projects, with direct reportsConducted Initiation, Interim, and close out visits at clinical study sites for projectsDirect mentoring and oversight responsibilities of Senior CRA staffContract Assignment with Takeda Global Research & Development Center, Inc.Senior Clinical Trial Manager, Clinical OperationsContributed to protocol synopsis development and to Clinical Development Plan (CDP)conducted global Phase 1 clinical studies with vendor oversightActively conducted Initiation, Interim Monitoring, and close out visits at clinical study sites while in a management roleLed in the evaluation and selection of all vendors for assigned studies.Responsible for managing assigned study(ies) within budget; provide the latest best estimate of study budget according to Company processes; provides guidance to study team on changes to study budgetParticipated in the evaluation and selection of study sites/investigators in collaboration with the Program ManagerCoordinated study-related meetings and provided protocol-specific training to investigators, clinical site personnel, monitoring staff and/or vendor personnelAssisted in the design/ review/ and development of case report forms (CRFs), CRF guidelines, study manuals, data management edit checks, and data collection tools to ensure that they adhere to protocol and Company standardsMaintained project tracking system with current study status and provided accurate progress reportsBaxter Healthcare Corporation, Bioscience, Deerfield, ILClinical Project ManagerServed as Interim Project Manager for a multi-center global Phase 3/ 4 Hemophilia randomized surgery trial and took over study management responsibility in the US and also managed another key Phase I studyActively conducted routine monitoring visits, including initiation, interim, and close out for a number of clinical sites across two protocolsConducted and led US Investigator/ CRO/ CRA training including comprehensive protocol reviewUtilized CTMS for multiple projects tracking and reports management toolsCompleted CTMS Study Manager Training Courses including Productivity Changes Release TrainingLed Request For Proposal (RFP) process for central labs, CRO, and recruitment vendors for key Baxters Top Project(also includes responsibilities listed below)Trained and supervised in-house CRA staff4/7 - 7/10Contract - Assigned to Baxter Healthcare Corp., Bioscience, Deerfield, ILSenior CRAManaged all aspects of initiation of a key phase I clinical study, including management of the CRO activities, protocol development, initiation of contracts/ budgets w/ vendors, Core Labs, ICF Template development, site selection/ start-up, DSMB/ CEC oversight, IRB submissions, planning and coordinating Kick-Off and Investigator MeetingsServed as Clinical Study Team Lead in management/ oversight activities of key Phase II stem cell trial w/ planning and coordination of Ad Board and expert panel meetings as well as planning/ projected enrollment timelines/ budgets and all start-up activities for potential pivotal (Phase III) trial for Chronic Myocardial Ischemia (CMI)Provide oversight and assist in Management of key recombinant VWD trial, serving as the lead Sr. CRA for all US sites and actively monitoring clinical sites in a global super BTP Phase II study- one of Baxters top initiativesEffectively address FDA issues/ concerns throughout the conduct of the clinical trialsDevelop clinical strategies and project plan to efficiently manage the project and maintain regulatory complianceReviewed contracts/ budgets/ and conducted CRO oversight to ensure appropriate management of the trialUtilized CTMS for multiple projects tracking and reports management toolsManaged Clinical Application Specialists in the development of training and monitoring plans for Batch Record production and retrievalInitiated and chaired the first Global CRA meeting within Baxter Bioscience promoting innovation, growth, and development across regions for Clinical OperationsParticipated at Investigator Meeting for a Phase IIb Global Mesh Graft biosurgery study as a potential trainer for use of Easy Spray Device at Clinical sitesAssisted in budgets/ planning for upcoming Hemophilia trial and related sub-studiesServed as primary contact with Global Pharmacovigilance for the Clin Ops team ensuring harmonization of Safety processes/ SOPs are successfully achievedServed as a backup to assist and support the Sr. Clinical Project Manager, as needed including training and supervising over junior in-house CRA staff1/06 - 4/07Contract assigned to Kendle International, Northbrook, ILSenior CRA IIICompleted project activities associated with monitoring functions of Phase I-IV clinical research studies while continuing to develop knowledge of drug development processes, GCPs, ICH, and relevant FDA regulationsResponsible for management/ oversight of 22 clinical trial sites for various ongoing Phase I through III studies in the areas of prostate cancer, Osteoarthritis, and Diabetic NeuropathyProvided clinical and technical support for CRA I/ CRA II including relevant training and overview of the project(s) as neededPerformed management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines SOPs and Project Specific SOPs are metParticipated and presented as CRO representative at key Investigator Meetings for various sponsor led trialsAssumed the role of Lead CRA on projects as needed10/04 12/05Pharmaceutical Resource Corporation (PRC), Hatboro, PASenior Clinical Research Associate (10/04 12/05)Trained and mentored junior CRA staff while independently training study coordinators/ investigators on all aspects of the protocol(s)Represented PRC in the pharmaceutical industry, medical research community as a primary resource for site personnel and the research project team and developed collaborative relationships with investigative sites and Sponsor clientsIndependently evaluated and recommended selection of investigators/ study sitesManaged all aspects of clinical trial monitoring from Pre-Study through Closeout for multiple Clinical Research projects at various phases and in a variety of therapeutic/ medical research areas, including, but not limited to, Diabetic Neuropathy, AIDS/ HIV, Urology, and Oncology (Prostate Cancer), in accordance with ICH/ GCP guidelines.01/04 10/04Baxter International Cellular Therapies, Round Lake, ILRegulatory Affairs Associate III (01/04 10/04)Responsible for overseeing all international import/ export regulations for the Cellular Therapies Division of Baxter International - multiple marketed products across multinational countries throughout the world.Responsible for all IND Submissions, Master Files, and annual reports supporting all divisional products marketed by Baxter through the Cellular Therapies Group7/00 1/04Baxter International, Transfusion Therapies Pathogen Inactivation, Round Lake, ILClinical Research Associate II/ IIIPrimarily responsible to oversee CRO activities, data management whileserving in the capacity as the lead CRA ensuring conduct and development of all Processing activities for the Phase III Red Cell Clinical Trials (both Acute and Chronic patients) for Pathogen Inactivation in North America, including management of 2 full-time contracts CRAs for the studyEnsured completion of all monitoring/ auditing activities for the Platelet Phase III Clinical Trials as well as RBC Trials, while managing all duties and responsibilities as described under Clinical Research Associate I experience01/99 7/00Baxter International, Fenwal Division, Pathogen Inactivation, Round Lake, ILClinical Research Associate I (01/04 10/04)Responsible for assisting, coordinating, and monitoring the conduct of all aspects of global Clinical Trials for key Phase III Clinical Studies for both acute and chronic leukemia patients (AML, CLL, sickle cell and thalassemia), for transfusion therapiesPrepared and executed Clinical Research protocols, summaries, and final reports to meet FDA and other agency requirementsDeveloped effective training tools for both CRAs and Site Coordinators as well as performing site evaluations through closeout visits and clinical auditsPrepared project status/ quarterly site updates, identified data trends, analyzed and interpreted study data, managed timelines for sites, independently provided training for investigators/ study coordinators and site personnel10/94 12/98Baxter Healthcare Corp./ Fenwal Division, Round Lake, ILResearch Scientist (10/94 08/99)Responsible for coordination and supervision of all aspects of in vitro GLP studies for global regulatory submissions including supervision of two full-time PhysiologistsManaged all aspects of blood physiology labs, including, preparation,designed and conducted large and small-scale physiology studies in support of Pre-Clinical trials, including review, preparation, design, and execution of research protocols and final reports providing engineering support in all phases of Clinical/ and non-Clinical studies.06/92 10/94Abbott Laboratories, Abbott Park/ NC, ILResearch Analyst (04/93 -10/94)Designed and conducted a variety of GLP, GMP studies, both lab scale and in production to implement a new drug development process.Operated and maintained instrumentation systems for retrovirus labsConducted enzyme immunoassay studies designed to test HTLV/ HIV antigens on polystyrene-coated beads; evaluated/qualified multiple lots using both manual and automated systems under assay developmentCommunicated and maintained effective liaison with several departments and groups to streamline the implementation of a new freeze-drying technique for a new parenteral drugImplemented a highly effective filtration system into a manufacturing plant to eliminate impurities for a pulmonary lung surfactant for premature infantsPROFESSIONAL MEMBERSHIPSAmerican Association for the Advancement of Science since 2000American Association for Clinical Chemistry since 2003EDUCATIONJan. 2008M.S. Summa Cum Laude Applied ImmunologyDartley University, Wilmington, DE1992B.S. -BiochemistryUniversity of Illinois, Chicago, IL |
