0000091661-CRO Trials Consultant (4m) at Cambridge

Job Description

JOB DESCRIPTION:Candidate will be responsible for: Supporting the Senior Director of R&D Strategic Projects in coordination with the Clinical Developmental Operations work teams on clinical trial strategy work plan; Advising the development of a long-term clinical trial communications platform with internal (Clinical DevOps and Trial Start-up Teams) and external stakeholders; Extensive experience in site feasibility analysis and site selection metrics; Ensuring critical trial recruitment goals and internal operational milestones are met on a timely basis; Working with internal clinical stakeholders to develop early-stage (Phase I and Phase II) trial execution strategy; Aligning internal trial start-up teams and clinical research unit operation groups on trial objectives.JOB REQUIREMENTS:EXPERIENCE: 15+ years of global clinical trial operation experience at a major pharmaceutical company or clinical trial contract research organization. Candidate will have extensive clinical trial management experience from the trial site feasibility and identification, including PI leadership, through launch and completion. Particular focus on successful execution of early-stage trial strategy (Phase I and Phase II) is strongly preferred.EDUCATION: Advanced degree recipient with specific focus in pharmaceutical company clinical affairs related to trial execution.SkillsImportanceExperienceCompetencyFDA RegulationsClinical/Pharmaceutical:All:Clinical Trials Associate:Certification/Compliance Training2. Required7+ Years3. AdvancedClinical Trial Safety ReportingClinical/Pharmaceutical:All:Clinical Trials Associate:Industry Skills2. Required7+ Years3. AdvancedClinical Trials - Phase IClinical/Pharmaceutical:All:Clinical Trials Associate:Industry Skills2. Required7+ Years3. AdvancedClinical Trials - Phase IIClinical/Pharmaceutical:All:Clinical Trials Associate:Industry Skills2. Required7+ Years3. AdvancedORL

Job Requirements

 
Country: USA, State: Massachusetts, City: Cambridge, Company: InVentiv Health.