Job Description:
• Lead study teams in planning and execution of Phase 1 clinical development studies
• Manage study management activities including timeline, risk, and budget management
• Communication across functional personnel and third-party organizations
• Identify and communicate status of ongoing projects, issues, and risks
• Track study-level spend and manage change needs
• Develop and negotiate study budgets with cross-functional personnel
• Initiate contracts and manage investigator payments
• Ensure compliance with protocol requirements and local regulations
• Provide clinical process expertise and ensure accurate study-level documentation
Requirements:
• Bachelor’s degree (scientific or health‑related field preferred)
• At least 3 years of clinical research experience or relevant experience in a scientific or health‑related field
• Advanced degree (Master’s, PharmD, PhD, etc.) in a scientific, health‑related, or relevant field can also be considered
• Strong leadership and networking skills
• Proven problem-solving abilities
• Strong self-management, organizational and interpersonal skills
• Ability to travel (up to 10% expected)
• Understanding of regulations and guidelines that apply to conduct of studies
• Strength in Excel, Project, risk management tools, budget monitor & control tools
• Previous experience working in cross-functional teams or projects
Benefits:
• Comprehensive benefit program including health, dental, and vision insurance
• Eligibility for a company-sponsored 401(k)
• Pension benefits
• Paid time off and leave of absence benefits
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• Life insurance and death benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits)
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