This individual will be responsible for leading one or several clinical trials within the Clinical R&D Operations CoE, as well as fostering strong, productive relationships with colleagues across the organization. Serves as the trial leader for clinical study execution.
The Staff Clinical Project Leader will:
• Serve as a Staff Clinical Trials Leader within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device Franchises
• Manage all operational activities of assigned clinical studies within the Clinical R&D Operations group
• Serves as a member of the clinical trial/study/program core team and may serve as the liaison with the Clinical R&D Franchise and Clinical R&D BSDM for projects under his/her responsibility
• May serve as the primary contact for clinical trial sites
• Independently solves 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 R&D Operations and R&D Clinical Franchise as needed
• Plan, track, and manage assigned clinical trials/programs budgets to ensure adherence to business plans
• Support the implementation of new clinical systems/processes, and provide support for publications, 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
• Act as an operational expert rotating to new projects to provide technical expertise and training in starting new studies.
• Support Senior CTM or CTM within a large or complex regulated clinical study/program.
• Exhibit proficiency and act as a Subject Matter Expert in clinical trials involving complex design issues. May provide solutions and guidance on complex situations.
• Manage work done by CROs under CTM/Senior CTM guidance.
• Identify and ensure strategies, resources, and accountabilities are in place to achieve rapid, cost-effective, and high quality execution of assigned clinical studies/programs, including those assigned to direct reports.
• Review and provide feedback on clinical operation section of protocols with minimal supervision.
• A minimum of a Bachelor’s Degree is required, preferably in Life Science, Physical Science, Nursing, or Biological Science
• MS or PhD is preferred
• A BS with at least 6 years of experience, MS with at least 5 years of experience, or a PhD with at least 3 year of relevant experience is required
• Previous experience in clinical trial management or equivalent is required
• Experience working with neurovascular is preferred.
• Experience working well with cross-functional teams is required
• Relevant industry certifications are preferred (i.e., CCRA, RAC, CDE)
• Experience managing others is preferred
• Clinical/medical background is preferred
• Medical device experience is preferred
• This position may require up to 30% travel
Requisition ID: 0391170915