Clinical Team Manager/Sr. (CTM) - FSP

About This Role

The Clinical Team Manager/Sr. (CTM) is responsible for ensuring the final clinical deliverables are met within contractual timelines and quality standards. This role involves managing monitoring operations, developing clinical tools, and collaborating with various stakeholders to improve health outcomes and accelerate therapeutic delivery.

Responsibilities

• Manage all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations.
• Develop clinical tools and study plans, collaborate with Biogen CSO, and lead team meetings to maintain timelines, resources, and quality.
• Serve as a clinical subject matter expert for protocol and a point of escalation for site managers.
• Ensure timely deliverables, monitor trials, communicate with study sites, and coordinate start-up activities.
• Address regulatory requirements and provide input on forecast estimates and resource management.
• Complete trip report reviews in compliance with study plan timeline.
• Escalate issues per plan and identify/report site performance issues and conduct trend analysis.
• Perform accompanied site visits with site managers and attend Sponsor meetings to discuss study progress and updates.
• Generate monitoring plan and trip report completion annotations.

Requirements

• Bachelor's degree
• 5+ years of relevant experience
• Clinical trials monitoring skills (remote and onsite)
• Understanding of company's SOPs, WPDs, and relevant regulations (ICH/GCP, FDA guidelines)

Qualifications

• Bachelor's degree
• Previous experience comparable to 5+ years, with preferred experience in Monitoring or Study Management, and Oversight. Extensive Neuroscience experience and prior client-dedicated experience are also preferred.

Nice to Have

• Monitoring or Study Management and Oversight experience
• Extensive Neuroscience experience
• Prior client-dedicated experience

Skills

* Required skills

Benefits