Clinical Team Manager

Description

• Manages all aspects of monitoring operations and quality for assigned studies, ensuring compliance with ICH GCP and applicable local regulations
• Develops clinical tools and study plans, collaborates with Biogen CSO (to include but not limited to CCSLs) and leads team meetings to maintain timelines, resources, and quality. Serves as clinical subject matter expert for protocol and point of escalation for site manager as applicable
• May include reginal coordination with regional CMLs.
• Ensures timely deliverables, monitors trials, communicates with study sites, coordinates start-up activities, addresses regulatory requirements and provides input on forecast estimates and resource management.
• Completes trip report reviews in compliance with study plan timeline.
• Issue escalation per plan, responsible for identifying and reporting site performance issues, trend analysis
• May perform accompanied site visits with site manager and may attend meetings with Sponsor to discuss, but not limited to country/region start up progress, trending and issue identification/escalation, and general site/country updates.
• Generate monitoring plan and trip report completion annotations

Qualifications

• Bachelor's degree and previous experience comparable to 5+ years.
• Monitoring or Study Management, and Oversight experience preferred.
• Extensive Neuroscience experience preferred.
• Prior client-dedicated experience preferred.

Knowledge, Skills and Abilities:

• Advanced mentoring/leadership/supervisory skills
• Excellent clinical trials monitoring skills; ideally remote AND onsite experience
• Demonstrated understanding of or ability to learn the company’s SOPs, WPDs, and relevant regulations (e.g. ICH/GCP, FDA guidelines)
• Strong organizational and negotiation skills
• Strong attention to detail
• Advanced written and oral communication skills
• Strong knowledge of English language and grammar
• Demonstrated use of computer to include data entry, archival and retrieval
• Ability to travel as needed
• Excellent team player with team building skills
• Excellent interpersonal and conflict resolution skills
• Advanced ability to utilize problem-solving techniques applicable to constantly changing environment
• Solid knowledge of medical/therapeutic areas and medical terminology