Clinical Trial Manager

Responsibilities

• Responsible for the day-to-day management of assigned operational aspects, such as CRO/vendor management, drug supply management, management of clinical sites, etc. for assigned region(s) or study(s)
• Manages high impact vendors, including oversight of timelines and contracts (invoicing, purchase order monitoring, and forecasting)
• Oversee development and maintenance of study documents such as Study Timelines, Vendor Management Plan, Risk Management Plan, Informed Consent Form, Monitoring Oversight Plan, CRFs, Study Reference Manual, dashboards, etc
• Lead, or actively contribute to, Study Management Team meetings
• Identify study risks, develop and implement mitigation strategies
• Oversee Trial Master File, Completeness Reviews, and Essential Document List
• Serve as a subject matter expert on initiatives and working groups
• Mentor Clinical Operations Staff (Clinical Trial Associates, Specialists, CTMs), including onboarding of new hires

Requirements

• Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred)
• Typically 6 years of direct work experience in Clinical Research, with international experience from study start up through closeout preferred
• Fully proficient in the management and execution of clinical trials
• Excellent planning, organizational, and communication skills
• Able to handle multiple tasks and deadlines; and identify risks and issues and take appropriate actions
• Must be self-motivated and able to develop solutions for a variety of complex problems where analysis requires an in-depth evaluation of variable factors, including inter-organizational impact
• Ability to build and maintain positive relationships with management, peers, vendors, and clinical sites
• 10% travel may be required