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Pioneer Data Systems Inc

Pioneer Data Systems Inc is looking for a Clinical Research Associate-CRA / Feasibility Process (Remote-Work)  #EmploymentBankPagosaSprings #JobHuntingPagosaSprings #ResearchJobsPagosaSprings

Our client, a world leading Pharmaceutical Company in Remote is currently looking for a Clinical Research Associate-CRA / Feasibility Process (Remote-Work)to join their expanding teamPosition Details:Job Title: Clinical Research Associate-CRA / Feasibility Process (Remote-Work)Duration: 06 months contract, extendable up to 18 monthsLocation: RemoteNote:Client has the right-to-hire you as a permanent employee at any time during or after the end of contract.You may participate in the company group medical insurance planJob Description:Job Title: Feasibility Leads (2) this is NOT Global Trial Management Assistantremote based positionNotes:2 positions for 6 months contractMust have Clinical trial feasibility experienceRead protocols and understand clinical and scientific aspectsMust have Knowledge of country + site selection processExperience in Pharma + working in Feasibility group at CRO is PLUS, Will consider 3rd party data providers alsoInflammation/Immunology/oncology helpful, will consider candidates from any therapeutic areaSite Management experience is not requiredClinical trial is currently is in Phase II/Phase IIISummary: Feasibility LeadPartners with CROs and Clinical Operations to develop and deliver rapid, accurate and robust assessments of program and country feasibility, oversight of site identification/site feasibility, and timing of key start-up and recruitment milestones. Focusing on data driven estimates, benchmarking assumptions, robust scenarios & accurate planning.Works under close supervision of Senior Director “ Feasibility Group Lead to support therapeutic areas as needed (i.e. therapeutic area agnostic).Role Responsibilities:Supports and Manages processes relating to Program, Protocol, Country & Site feasibilitySupports Patient Recruitment Plans in collaboration with Patient Recruitment Strategy GroupSupports Protocol Optimization StrategiesParticipates in global initiatives to improve operational efficienciesSupports Clinical Operations in the build of data driven study assumptions from operating plan to study work orderSupport/advise the Site Identification and Site Feasibility ProcessMaintains continuity connecting and documenting changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Recruitment & Start Up PlanningIn support of Clinical Operations, responsible for delivery of early feasibility (before core protocol elements are available)Support Clinical Operations roles early in the development cycle, providing initial enrollment timelines, High Level Budget (Op Plan), potential Country Footprint, develop key assumptions.Support Clinical Operation roles in Optimizing Operational Protocol DesignSupport Clinical Operation roles in ensuring effective scenario generation & planning; comparing Pharmaceutical’s past performance data and proposed scenarios from CROsPartner with CROs to build system, processes and work practices that drive rapid, accurate and robust assessments of program, country and protocol feasibility (country, site) as well as the timing of key recruitment milestones.Support the development of data driven study / program assumptions.Support governance processes by providing early feasibility information leveraging existing data sources and organizational knowledge/expertisePartners with CROs, Clinical Operations teams, and RU/BU partners to improve overall study start up metrics and implement simple processes.Operational responsibility for delivering to agreed set of KPIs for assigned protocols.Promotes a continuous improvement culture to streamline appropriate processes for maximum efficiency and productivityInfluences alignment of business strategies that promote the widespread implementation of suitable clinical trial technologiesMaintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitates effective portfolio deliveryRequirement:Mandatory of at least BA/BSBS/Equivalent “ 4 yearsMS “ 3 yearsPhD/MD “ 2 yearsthese are Feasibility Lead roles & NOT Global Trial Mgmt rolesA broad based experience clinical research, including clinical trial conduct, Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operationsHistory of success in a customer service role with demonstration of meeting customer expectations.Effective verbal and written communication skills in relating to colleagues and associates both inside and outside the organizationWell-developed strategic planning, observation, analytical operational execution and problem-solving skillsExceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflictTechnical Skill Requirements:Demonstrated knowledge of clinical research processes and regulatory requirements.Demonstrated success/results in prior roles including matrix organizationKnowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategiesDemonstrated ability to manage projects and cross-functional processes requiredDemonstrated platform skills; experience presenting to non-science populationsComments:UPDATES: this is NOT a Global Trial Mgmt. position — this is for Feasibility Lead positions!!Notes:Clinical Trials Feasibility experienceknowledge of country + site selection processknowledge/experience in Drug Development (operational perimeters of process)preparing & delivering presentations to study teams (research, data analysis)candidates with experience as Clinical Project Managers, Clinicians, or Study Managers preferredExperience in Pharma + working in Feasibility group at CRO is PLUS!! (3rd party data providers also)Recommended skillsClinical ResearchClinical Trial Management SystemsClinical TrialsFeasibility ProcessFeasibility StudiesStrategic PlanningRecommended JobsClinical Research AssociateResearch AssociateAtlanta,GaResearch Associate, Atlanta,GaClinical Research Associate-CRA / Feasibility Process (Remote-Work)Pioneer Data Systems IncWork From HomeFull-TimeClient Solutions ManagerLorienAtlantaProduct Manager (Remote)Open Systems TechnologiesAtlanta

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