Senior Clinical Trial Manager

The role

The Senior Clinical Trial Manager will provide trial management support for oncology programs. This person will manage CROs and study vendors while ensuring compliance with regulatory guidelines and internal SOPs.

What you will do

• Act as Clinical Operations point of contact for clinical study execution
• Manage clinical CROs and other study vendors from initial contact to final deliverables
• Lead external trial management teams to ensure conduct in accordance with regulations and guidelines
• Ensure coordination of CRO activities including monitoring, data management, and safety
• Provide operational input into study documents such as protocols and informed consent
• Develop and maintain study deliverables like timelines and study plans
• Identify potential study risks and implement mitigation actions
• Develop and coordinate study training and materials
• Attend in person and virtual study site visits
• Support management and maintenance of the Trial Master File

Required qualifications

• Bachelor’s degree, or equivalent, in a biomedical, life science or related field of study
• 5-8+ years of trial management experience as primary Clinical Trial Manager (or equivalent) within Pharma, Biotech or CRO
• Oncology experience required
• Strong understanding of global regulatory and compliance requirements for clinical research
• Strategic understanding of how outcomes, budgets, and timelines are impacted by decisions
• Outstanding teamwork, organizational, interpersonal, and problem-solving skills
• Effective communicator both verbally and in written form
• Ability to influence and collaborate well with colleagues and partners

About the company

Treeline Biosciences is a growing Clinical Development group.