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Organization TypePublic Interest
Years of Experience
Date Last Verified
ProfileDirector Duties: Develop, define, and implement overall Strategy and vision for the Center. Develop and drive project initiatives and concepts based on evolving nature of multi-regional clinical trials nationally and globally;. Define and refine project scope to determine deliverables and Center commitment; Periodic review of MRCT Center strategy and execution to goals to ensure maximum impact; Optimize impact/success of MRCT work nationally and globally. Communicate and disseminate strategy and vision externally; Proactively evaluate ethical and operational issues in global trials; Examine differences between Industry and academic clinical trials to identify best practices and opportunities in each; Develop presence in pedagogy and education in oversight and execution of global clinical trials. Report to and engage External Advisory Board on impact of MRCT Center. Identify, scope, and direct projects related to the MRCT mission and goals: Identify potential areas to improve the design, conduct, and oversight of multi-regional clinical trials; Drive MRCT work plan from initiative/project conception through adoption or dissemination; Ensure diverse stakeholders are represented on project workgroups; Oversee projects to ensure timelines are met. Oversee operations and all management aspects of MRCT center functions including: Develop and maintain stakeholder relationships with diverse groups including industry, academia, advocacy, regulators, and participant and patient advocates. Oversee MRCT staff and Advisors, including monitor annual goals and managing work distribution. Oversee MRCT project teams; Engage with and manage Steering Committee and Executive Committee to highlight impact of MRCT Center; Serve as a point of contact for external inquires and issues. Oversee budget in collaboration with DGHE Administrative Director; Recruit stakeholders for sponsorship or support of MRCT; In collaboration with MRCT Faculty Director, identify and apply for grant funding; Plan and facilitate MRCT Annual Meeting, External Advisory Board meetings, and Bioethics Collaborative. Develop MRCT Center processes and procedures to ensure efficiencies and optimal use of all resources.
Qualification and Experience
Qualifications: Advanced degree(s) such as MPH, PhD, JD Degree, MD. Significant experience with the conduct of clinical trials, global clinical trial challenges, bioethics, and laws and regulations relating to clinical trials and human subjects research. 5+ years of clinical research or clinical research operations experience. Experience working with the following institutions: academic research institutions, pharmaceutical and other life sciences companies, IRBs/research ethics committees, international NGOs, researchers and research institutions throughout the world. Experience managing a team with appropriate delegation Excellent written and oral communication skills. Ability to work independently and collaboratively. Internal and external professional presence, with documented ability to represent the Center to external parties. Solid understanding of laws, regulations and professional standards (U.S. federal and state, non-U.S. national, and international) governing clinical research. Demonstrated experience working with multiple internal and external constituencies. Direct IRB related experience. Thorough knowledge of research compliance with managerial and fiscal experience. Superior interpersonal and communication skills. Ability to problem solve and thrive in a dynamic environment. Strategic planning, organizational, and project management skills essential. Teaching experience, particularly as relates to clinical research, is a plus.