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In collaboration with Scientific Affairs (SA) Biostatistics group and Clinical Affairs (CA) Operations, the CS is responsible for execution and project management of their studies.
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The candidate should also have the communication skills and relationship skills necessary to interact with school district leaders in an advisory capacity, and the project management and supervisory skills necessary to lead ESS clinicians and to lead ESS work in improving mental health outcomes in school districts.
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Represents Clinical Affairs line in program-wide functions on Clinical Project Team, Medical Sub Committee, Clinical Study Teams, Asset Team, Program Teams, and Regulatory Strategy teams as applicable.
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Influences management/senior management decisions and is viewed as the Subject Matter Expert on CS decisions impacting a program and potentially the Medical/Scientific Affairs groups. As lead of the Study Core Team the CS will lead via a matrix organization Epidemiology, Biostats, Clinical Operations, Medical/Scientific Affairs, Regional, Pfizer laboratory assay group, and external team members.
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The Director, Clinical Project Management will manage assigned project (s), including program's strategic direction, integrated project plan, alliance management, cross-functional deliverables as required by the International Project Team. This role requires interaction with, and management of, internal cross-functional team members, business partners, and contractors.
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Oversee Data Management in partnership with Medical Director(s) to develop Data Review Plan and co-lead execution of routine cross functional data review for defined study/program milestones (Dose Escalation Meetings, Interim Analysis, Annual Safety reports, IB Updates, Database Lock, CSR, Publications, etc.
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In collaboration with Clinical Science and Project Management, contribute to or review regulatory and clinical documents including Clinical Reports, Informed Consent Forms, pre-market submission documents, and responses to regulatory authority inquiries.
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Identifies issues in a timely manner, leads implementation of complex solutions, and/or escalates as appropriate working with Clinical Affairs Lead, Clinical Epidemiologist/Medical/Scientific Affairs Lead and Partner representatives.
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Six Sigma (Green Belt or Black Belt), Project Management Professional (PMP) certification preferred. Prefer experience in continuous and project management improvement in complex hospital or patient care delivery systems.
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Strong project management and computer skills required, including robust Computerized Maintenance Management System (CMMS) software experience. Extensive healthcare experience with strategic planning, project management, analytical and program evaluation to continually examine systems and to develop or revise to accommodate change requirements.
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As Director, Clinical Supply Planning and Project Management, you will lead all clinical and commercial supply planning activities across the supply chain. Support Pivotal Readiness and Late-Stage Project Management across CMC.
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Reporting to the Global Safety Director, this position will provide leadership, management, and direction for Clinical Safety for Abbott’s clinical trials. Support projects or other initiatives from cross-functional groups and departments (i.e., Project Management teams, Scientific group, Quality/Compliance, Data Management, Biostatistics and Regulatory Affairs), and ensure adequate safety support and timely update of safety information to internal and external stakeholders.
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G., clinical operations, regulatory, preclinical, project management, quality, CMC, etc.) in the creation, management, and execution of one or more clinical trials/programs, in developing innovative and efficient solutions to medical and scientific clinical trial issues, and ensuring the successful execution and completion of Abdera's clinical trials.
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The Director, Clinical Project Management works cross-functionally with the Epidemiology, Biostatistics, Clinical Informatics, Engineering, and Data Science teams to drive the scoping and execution of new projects.
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Strong collaboration and partnership with cross functional colleagues globally (Clinical Development, Project Management, PVE, Regulatory, Biometrics, Clinical Pharmacology, CSM, Medical Affairs, etc) to ensure on-budget, timely, high quality delivery of the programs.
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project management jobs Title: director clinical in Troy, New York
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