Senior Clinical Trial Manager

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Provide guidance and leadership to the clinical site management team members from the beginning to the end of the study.

• Supervise regional Clinical Trial Managers (CTMs) and coordinate efforts among the CTM team.

• Represent Site Management concerns during Sponsor, Investigator, and bid defense meetings.

• Serve as the primary point of contact for activities throughout the study.

• Contribute to the overall project plan by developing a comprehensive global monitoring strategy for site initiation, enrollment, site management, and closeout phases.

• Assign sites on behalf of the sponsor.

• Provide consistent input to project tracking systems, financial performance reports, study metrics, and trends.

• Support the allocation of resources to project tasks and monitor time recognition.

• Collaborate with Business Development, Regulatory, Study Start-up, and Project Management teams to anticipate requirements and achieve study objectives.

• Oversee site qualification, initiation, interim monitoring, site management, and study close-out activities.

• Monitor data metrics and project planning to ensure data quality and timely completion.

• Ensure proper reporting and follow-up for safety events by site personnel.

⛳️ Requirements

• Exceptional oral and written communication skills in English.

• Strong planning and organizational skills with effective time management abilities.

• Excellent interpersonal skills with the ability to work and influence across diverse cultures.

• Outstanding presentation skills.

• Capability to lead and motivate a remote team across different time zones.

• Solid understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements.

• Four-year college degree or equivalent in biological, physical, or health studies, plus at least four years of experience as a Senior Clinical Research Associate or equivalent.

• OR a two-year college degree or equivalent education/training, with a minimum of six years as a Senior Clinical Research Associate.

• At least 2 years of relevant experience as a CTM/LCRA or equivalent, including overseeing a CTM team.

• Willingness to travel.

• A valid current passport is required.

• A driving license is required.

• A nursing degree or an equivalent life science degree is preferred.

🏝️ Benefits

• Competitive benefits package based on location.

• Remote work arrangement.