Senior Clinical Project Manager

ResponsibilitiesContribute to our cutting-edge radiopharmaceutical development programConceptualize, plan, design, place, execute, and summarize clinical trialsDrive daily vendor and site management, including collaboration with Study Medical Monitor and KOLs to determine the medical and scientific needsEffectively communicate project-related information including the planning and execution of meetings and presentations as well as creation and maintenance of metrics, e.g., dashboards, timelines, resources, and budgetsContribute to regulatory filings (e.g., IND / IMPD / CTN, NDA)Identify issues and propose solutions. Proactively assess potential risks to the clinical study and propose mitigation plansWork in an office (Wilmette, IL north of Chicago) with a dynamic, talented teamQualificationsMINIMUM EXPERIENCEBiotech or Pharma company clinical operations experience in progressively responsible positions, including Senior/Clinical Project or Trial Manager7+ years’ experience managing clinical trials including study design and initiation, oversight, study closeout, project management, and regulatory filingsDemonstrated ability to plan and execute Pharma-Sponsored clinical trials, managing vendors and resources in effective & creative manners to achieve business needs including on-time, on-budget, and on-spec study results for successful use in regulatory marketing applicationsThorough knowledge of ICH-GCP, Food and Drug Administration (FDA), and European regulationsExcellent communication (oral and/or written), leadership, and risk mitigation skills plus a positive attitudeRequire minimal guidance; is able to function in an independent mannerProven ability to effectively manage internal and external personnel in clinical trial conductPREFERRED EXPERIENCE9 years’ clinical trials experience in pharmaceutical or biotechnology firmsExperience in oncology trialsExperience managing clinical trials in Europe and/or AustraliaExperience in a small or growth-stage biopharma company