Manager, Monitoring & Site Management

Summary

Join Alimentiv as a Clinical Monitoring Unit Manager and be responsible for the day-to-day delivery of clinical monitoring services. You will plan, manage, organize, evaluate, and report on various aspects of the unit, including policy development, quality assurance, site monitoring, staff management, and performance management. The role involves supporting project and clinical monitoring teams, ensuring high-quality service delivery, and maintaining compliance with regulations and best practices. You will also manage third-party contractors and collaborate with internal and external stakeholders. This position requires a college diploma or university degree in a relevant field, along with several years of experience in clinical monitoring and staff management. The role is home-based, offering a competitive salary.

Requirements

• Have a College Diploma/University Degree in a relevant field (Health Sciences, Life Sciences preferred, or SoCRA and/or ACRP Certification/Designation)
• Have a minimum of 4-6 years related experience + substantial on-going training
• Have experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting setting
• Be able to work in a remote global capacity
• Have strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP
• Be a team player that has a customer service approach and is solution oriented
• Have demonstrated leadership skills
• Have strong verbal, written, and organizational skills
• Be able to handle multiple tasks to meet deadlines in a dynamic environment

Responsibilities

• Plan, manage, organize, evaluate and/or report on the day delivery of the Clinical Monitoring unit
• Develop and improve policies and processes related to product quality, site and compliance monitoring, staff resource planning, and staff and contractor performance management
• Provide support, expertise and represent project and clinical monitoring teams with sponsors/researchers throughout the project life cycle
• Ensure all team members, including third party providers, deliver high quality, timely service and maintain service delivery processes in accordance with corporate and industry best practices and that meet all regulatory requirements and guidelines
• Working in conjunction with clinical monitoring and project leadership team members, identify, develop, plan for, monitor, approve and/or report on project specific processes and services related to site selection, clinical monitoring, ICH-GCP compliance issue resolution, and global project harmonization including SOP and QS document maintenance, periodic site visits and collaborating with IT support to meet sponsor requirements on a timely basis
• Represent and support the Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, to address sponsor/site concerns and to integrate new technologies and processes
• Ensure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceeded
• Manage members of the Clinical Monitoring teams, ensuring functional areas are adequately staffed with qualified personnel, providing ongoing support to staff in the areas of work allocation, resource planning, training and development, technology, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management)
• Identify, procure, and manage Clinical Monitoring (CRA) Independent Contractor services, including needs assessment, recruitment, contract negotiations, Corporate and Sponsor policy compliance, training and development, cost monitoring and performance management, ensuring corporate, industry and regulatory service level, guidelines and regulations are maintained
• Provide expertise, developing tools to support project teams and business development in the areas of clinical, site and compliance monitoring and performance during the project life cycle starting from the bidding process through to reporting project findings to sponsors

Benefits

• Home-based
• $110,500 - $184,000 a year