Associate Director, Institution Sponsored Collaborative Studies
Employment Type: Full-Time
YOUR TASKS AND RESPONSIBILITIESThe primary responsibilities of this role, Associate Director, Institution Sponsored Collaborative Studies, are to:Leads the cross-functional review of study protocols, budgets,Informed Consents, CRFs, database structure, and other study management plans.Ensures internal project-related activities and/or interactions with study sponsors comply with applicable guidelines and regulations governing externally sponsored studies.Ensures assigned projects are resourced properly and executed within budget tolerances and in accordance with established timelines and quality expectationsManages internal stakeholder expectations for assigned studies(e.g., information requests from strategic committees, study update meetings for country MA advisors and/or MSLs, etc.).Leads and processes required approvals for assigned studies at governance committees (e.g., concepts, protocols, budgets, etc.).Manages interactions with study sponsors, ensuring appropriate internal cross-functional representation for any given project topic.Manages project core and extended team interactions for assigned studies in order to align on recommendations and requests for study sponsors.Leads and coordinates cross-functional efforts during transfers of study data for quality assurance measures and regulatory initiatives.Drives timelines for assigned studies.Assesses risks and obstacles to study performance and provides options for resolution.Leads a team and/or direct reports in support of assigned projects.Contributes to group, departmental, and/or organizational process improvement initiatives.Oversees and directs any activities outsourced to CROs and/or vendors.Provides support and coverage for other Data Generation programs within the Operational Excellence & Project Management group if assigned.WHO YOU AREYour success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:Required Qualifications:A Master’s degree with a minimum of 10 years’ experience in clinical research (e.g., Study Management, Project Management, Clinical Research Science, CRA/Monitoring, and Study Site Management) or a Bachelor's degree with a minimum of 15 years’ experience.A minimum of 5 years of Pharmaceutical or Biopharmaceutical experience A minimum of 3 years’ experience in oncology Demonstrated understanding of ICH/GCP and US/EU regulations governing clinical trials.Strong written, computer, and communication skills are required.Country: United StatesState: New JerseyLocation: WhippanyReference Code: 47312Functional Area:Medical Affairs & PharmacovigilanceEntry Level : Professional
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