Clinical Team Manager – Sr.

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Oversee all facets of monitoring operations and quality for designated studies, ensuring adherence to ICH GCP and relevant local regulations.

• Create clinical tools and study plans.

• Collaborate with Biogen CSO, including CCSLs, and lead team meetings to uphold timelines, resources, and quality standards.

• Act as the clinical subject matter expert for protocols and serve as the escalation point for site managers.

• Coordinate with regional CMLs as necessary.

• Ensure timely deliverables, monitor trials, communicate with study sites, coordinate start-up activities, address regulatory requirements, and provide insights on forecasts and resource management.

• Complete trip report reviews in accordance with study plan timelines.

• Escalate issues as per the plan and identify, report, and analyze trends in site performance.

• Conduct accompanied site visits alongside site managers as required.

• Participate in Sponsor meetings regarding country/region start-up progress, trends, issue identification/escalation, and site/country updates.

• Develop monitoring plans and complete trip report annotations.

• Deliver accurate data from evaluable patients within agreed timelines.

• Ensure clinical deliverables align with customer time, quality, and cost expectations.

• Maintain profitability by managing clinical activities within the scope of the contract.

• Independently manage projects of moderate to high complexity and potentially take on regional lead or Clinical Study Manager responsibilities.

⛳️ Requirements

• Bachelor's degree with prior experience equivalent to 5+ years.

• Preference for experience in Monitoring or Study Management and Oversight.

• Extensive experience in Neuroscience is preferred.

• Previous client-dedicated experience is preferred.

• Advanced mentoring, leadership, and supervisory abilities.

• Exceptional clinical trials monitoring skills, including both remote and onsite experience.

• Understanding of, or capacity to learn, company SOPs, WPDs, ICH/GCP, and FDA guidelines.

• Strong organizational and negotiation capabilities.

• Keen attention to detail.

• Advanced written and oral communication skills.

• Strong command of the English language and grammar.

• Proficient in computer skills including data entry, archival, and retrieval.

• Willingness to travel as required.

• Team-building abilities.

• Interpersonal and conflict-resolution skills.

• Problem-solving abilities in a dynamic environment.

• Knowledge of medical/therapeutic areas and medical terminology.

• Capability to communicate and comprehend information with diverse groups.

• Ability to work upright and stationary during standard working hours.

• Adaptability to work in non-traditional work environments.

• Proficiency in using and learning standard office equipment and technology.

• Ability to perform under pressure while prioritizing and managing multiple projects.

• Willingness to travel independently up to 20%.

🏝️ Benefits

• Annual incentive plan bonus.

• Healthcare benefits.

• Employee benefits.

• Opportunities for career development.

• Innovative and forward-thinking organization.

• Dynamic company culture focused on integrity, intensity, involvement, and innovation.