Clinical Trial Manager

Clinical Trial Manager Overview

• The Clinical Trial Manager (CTM) oversees clinical trial operations, ensuring high-quality deliverables within timelines and budget.
• Collaborates with cross-functional teams to manage study start-up through close-out activities in compliance with regulations.
• Provides leadership in managing clinical sites, vendors, and drug supply for assigned studies or regions.
• Develops and maintains essential study documents, including timelines, risk management plans, and monitoring oversight plans.
• Identifies study risks and implements effective mitigation strategies to ensure trial success.
• Supports financial processes, including budgeting, invoice review, and financial accruals for clinical trials.
• Mentors clinical operations staff, fostering professional growth and onboarding new hires.
• Serves as a subject matter expert on clinical trial initiatives and working groups.
• This is a remote, contract position with potential for extension.

Clinical Trial Manager Key Responsibilities & Duties

• Manage day-to-day operational aspects of clinical trials, including vendor and site management.
• Oversee development and maintenance of essential study documents and plans.
• Lead or actively contribute to Study Management Team meetings to ensure alignment.
• Identify and mitigate study risks, ensuring compliance with regulations and SOPs.
• Supervise Trial Master File completeness and essential document reviews.
• Support financial management, including invoice reviews and budget tracking.
• Mentor and onboard clinical operations staff to enhance team capabilities.
• Act as a subject matter expert in clinical trial management initiatives.
• Ensure effective communication and collaboration with internal and external stakeholders.

Clinical Trial Manager Job Requirements

• Bachelor’s degree in a scientific or healthcare discipline is required.
• Minimum of 6 years of clinical research experience, with international experience preferred.
• Proficiency in clinical trial management and execution, including vendor oversight.
• Strong planning, organizational, and communication skills to manage multiple tasks effectively.
• Ability to identify risks and develop solutions for complex problems.
• Experience with study budgeting, financial processes, and document management systems.
• Self-motivated with the ability to build positive relationships with stakeholders.
• Willingness to travel up to 10% as required.
• This is a senior-level role requiring strong leadership and mentoring capabilities.