Senior Clinical Trial Manager

🕒 August 10

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $112k - $222k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Provide leadership and direction to clinical site management team members from study start through closure • Oversee regional CTMs and coordinate efforts across the CTM team • Represent Site Management issues at Sponsor, Investigator and bid defense meetings • Act as main point of contact for activities through the study • Contribute to the overall project plan by formulating a global monitoring strategy for site initiation, enrollment, site management and closeout phases • Assign sites on behalf of the sponsor • Provide regular input to project tracking systems, financial performance reports, study metrics and trending • Support resource allocation to project tasks and time recognition • Collaborate with Business Development, Regulatory, Study Start-up and Project Management to anticipate requirements and achieve study goals • Oversee site qualification, initiation, interim monitoring, site management and study close-out activities • Monitor data metrics and project planning to secure data quality and timely completion • Ensure appropriate reporting and follow-up for safety events by site personnel

🎯 Requirements

• Excellent oral and written communication skills in English • Excellent planning and organizational skills with effective time management • Excellent interpersonal skills with ability to work and influence across diverse cultures • Excellent presentation skills • Ability to lead and motivate an assigned team dispersed remotely across time zones • Strong understanding of FDA and/or EU Directive regulations, ICH Guidelines and local regulatory requirements • Four-year college curriculum or equivalent with a major concentration in biological, physical or health studies, plus a minimum of four years as a Senior Clinical Research Associate or equivalent • OR two-year college curriculum or equivalent education/training, with a minimum of six years as a Senior Clinical Research Associate • Minimum 2 years relevant experience as a CTM/LCRA or equivalent, including overseeing a CTM team • Travel required • Valid current passport required • Driving license required • Nursing degree or equivalent life science degree preferred

🏖️ Benefits

• Competitive benefits package depending on location • Remote work arrangement