[Hiring] Senior Trial Master File Lead @ICON plc

Role Description

As a Senior Trial Master File (TMF) Lead at ICON, you will oversee the Trial Master File (TMF) management activities for clinical trials, ensuring compliance, and contribute to the advancement of innovative treatments and therapies.

Your focus will be on coordinating trial master file management delivery, resolving issues, and developing team capability.

• Leading the development and implementation of TMF processes and procedures.
• Overseeing the organization, maintenance, and quality control of TMF documents throughout the trial lifecycle.
• Collaborating with cross-functional teams to ensure TMF compliance with regulatory requirements and industry standards.
• Providing guidance and support to internal stakeholders on TMF-related matters.
• Identifying opportunities for process improvement and efficiency within TMF management.

Qualifications

• Bachelor's degree in life sciences, documentation management, or a related discipline.
• Minimum of 5 years of experience in clinical research with a focus on TMF management.
• Strong understanding of TMF regulations, guidelines, and best practices.
• Proven track record of successful TMF management in a clinical trial environment.
• Excellent organizational, communication, and leadership skills.
• Willingness to travel as required (approximately 5%).

Requirements

• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Benefits

• Competitive base salary and performance related incentives.
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable.
• Retirement and pension plans.
• Life assurance and disability coverage.
• Employee assistance programmes and wellbeing resources.
• Learning and development opportunities through structured training and career pathways.
• Benefits may vary depending on role and location.