POSITION DUTIES & RESPONSIBILITIES:
• Serve as a Clinical Trial Leader within Clinical Operations to execute company sponsored clinical trials
• Manage all operational activities of assigned clinical studies
• Serves as a member of the clinical trial/study/program core team and may serve as the liaison with the Clinical Franchise and Clinical BSDM for projects under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Can independently solve problems arising during clinical study execution, and will seek guidance for more complex problems, as needed
• Provide internal communication of important clinical data and events. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
• May be involved in other tasks to support Clinical Operations and Clinical Franchise as needed
• Track and manage assigned clinical trials/programs budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, as needed.
• Interface and collaborate with site personnel, IRBs/ECs, Competent Authorities/MoH, contractors/vendors, and company personnel
• Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety, and Environmental compliance
• Manage resources assigned to designated clinical studies to provide quality deliverables while maintaining optimal efficiency
FUNCTIONAL AND TECHNICAL COMPETENCIES:
• Requires knowledge of Good Clinical Practices
• Knowledge and understanding of application of regulations and standards applied in clinical areas/regions
• Effective leadership skills in a professional and ethical manner
• Strong Written and oral communication skills
• Demonstrated competencies in the following areas are required:
• Behave and lead in a professional and ethical manner
• Presentation skills and influencing of others
• Advanced technical writing skills
• Advanced project management skills with ability to handle multiple projects
EDUCATION & EXPERIENCE REQUIREMENTS:
Education
• Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required
Experience
• BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred
• Previous experience in clinical trial management (CRO or Sponsor) is required
• Experience working well with cross-functional teams is required
• Clinical/medical background a plus
• Medical device experience a plus
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