Manager, Monitoring – Site Management

🔥 10 minutes ago

🌲 North Carolina, Massachusetts, +3 more states – Remote

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💵 €76.5k - €127.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 1%

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Logo of Alimentiv

Alimentiv

201 - 500 employees

Founded 2020

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Alimentiv is a specialty contract research organization focused on gastrointestinal (GI) and liver diseases. With over 30 years of experience, Alimentiv offers a comprehensive range of clinical research and imaging services, including clinical trial management, site management, regulatory affairs, and precision medicine. The company is at the forefront of medical research and development, providing state-of-the-art imaging solutions and actionable biomarker insights. Alimentiv supports the development of GI compounds and is active in more than 60 countries, working with a network of medical and operational experts to accelerate clinical trials and patient recruitment.

📋 Description

• Plan, manage, organize, evaluate, and/or report on day-to-day delivery of the Clinical Monitoring unit • Develop and improve policies and processes • Monitor product quality, sites, and compliance • Plan staff resources and manage staff and contractor performance • Support, provide expertise to, and represent project and clinical monitoring teams with sponsors and researchers throughout the project life cycle • Ensure team members and third-party providers deliver high-quality, timely services in accordance with corporate and industry best practices and regulatory requirements • Identify, develop, plan, monitor, approve, and/or report on project-specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, global project harmonization, SOP and QS document maintenance, periodic site visits, and IT collaboration • Represent and support Clinical Monitoring teams with internal partners and external sponsors to identify improvements, address concerns, and integrate new technologies and processes • Manage Clinical Monitoring team staffing, work allocation, resource planning, training and development, technology, process development, expense management, employee engagement, and performance management • Identify, procure, and manage Clinical Monitoring independent contractor services, including needs assessment, recruitment, contract negotiations, policy compliance, training, cost monitoring, and performance management • Develop tools supporting project teams and business development in clinical, site, and compliance monitoring from bidding through reporting findings to sponsors

🎯 Requirements

• College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred), or SoCRA and/or ACRP Certification/Designation • Minimum of 4–6 years of related experience plus substantial ongoing training • Experience managing CRA staff • Ability to provide training and/or mentorship to colleagues on a 1:1 basis or in meetings • Ability to work in a remote global capacity • Strong knowledge of regulations and guidelines pertaining to clinical monitoring and GCP • Customer service-oriented and solution-oriented approach • Demonstrated leadership skills • Strong verbal, written, and organizational skills • Ability to handle multiple tasks and meet deadlines in a dynamic environment

🏖️ Benefits

• Bonus • Home-based/remote work

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