Clinical Trial Leader / Senior Project Leader - US Remote - FSP

Clinical Trial Leader

Parexel is seeking an experienced Clinical Trial Leader to provide strategic leadership and end-to-end oversight of complex global Oncology and Inflammation studies within a dedicated FSP partnership.

The Clinical Trial Leader (CTL) is a key member of Clinical Delivery Team nominated to a specific. CTLs are accountable for the set-up, execution and delivery of their assigned trial(s) and contribute to delivery of client's pipeline through accurate planning and efficient execution of trials that bring speed and value to participating subjects and sites. The CTL provides leadership and direction to the trial team (core and extended team members) and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and key performance indicators. They are responsible for steering and directing clinical trial activities, including patient and site engagement activities, direct communication, and interaction with multiple internal and external stakeholders (e.g. investigative sites) and team members on a global, multi-country or regional basis. The CTL is responsible for managing the planning, implementation, and tracking of the clinical trial process as well as risk mitigation. The CTL serves as a proactive member of the clinical delivery team, liaising closely with the Clinical Trial Managers ("CTM") on all study-related issues. As leader of the Trial Team, the CTL communicates trial status to stakeholders, escalating issues as appropriate.

Key Accountabilities

• Trial Preparation
• Trial Conduct
• Trial Closeout and Reporting
• Contributions to Trial Strategy
• Leadership Competencies
• Compliance with Parexel Standards

Skills Required

• Strong Communication Skills
• Scientific and Operational Expertise
• Leadership and Influence
• Strategic Mindset
• Coordination and Oversight
• Project Management

Experience Required

• 5+ years of full scope global clinical trial project management experience. In-depth understanding of project management with emphasis on team work to promote high-performance teams
• Experience in Oncology or inflammation Phase III trials is required.
• Understanding of major regulations (US FDA, EMA and PMDA)
• Familiarity with guidelines and standard of care is desirable
• Cross geographical experience. Working in multi-cultural environment; strong understanding of corporate culture and cross-cultural dynamics
• Strengths in mentoring/coaching
• Demonstrated competencies in Agility, Accountability, and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, results orientation, and smart risk-taking

Education

• Requires a university degree (e.g. bachelor's or advanced degree). Major focus: Biomedical Life Sciences.

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.