Manager, Monitoring & Site Management (US)

Alimentiv•Nashville, TN

1d•$110,500 - $174,000•Remote

About The Position

This role is responsible for planning, managing, organizing, evaluating, and reporting on the day-to-day delivery of the Clinical Monitoring unit (Clinical Operations Leads). The responsibilities include policy and process development and improvement, product quality, site and compliance monitoring, staff resource planning, and staff and contractor performance management. The role also involves providing support, expertise, and representing project and clinical monitoring teams with sponsors/researchers throughout the project life cycle. A key aspect is ensuring 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, meeting all regulatory requirements and guidelines.

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 related experience.
Substantial on-going training.
Experience in managing CRA staff.
Ability to provide training and/or mentorship to colleagues on a 1:1 basis or in a meeting setting.
Ability to work in a remote global capacity.
Strong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCP.
Team player with a customer service approach and solution-oriented mindset.
Demonstrated leadership skills.
Strong verbal, written, and organizational skills.
Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Nice To Haves

SoCRA and/or ACRP Certification/Designation

Responsibilities

Plan, manage, organize, evaluate, and/or report on the day delivery of the Clinical Monitoring unit (Clinical Operations Leads).
Develop and improve policies and processes.
Oversee product quality, site and compliance monitoring.
Manage staff resource planning and staff and contractor performance.
Provide support, expertise, and represent project and clinical monitoring teams with sponsors/researchers.
Ensure team members and third-party providers deliver high quality, timely service in accordance with best practices and regulatory requirements.
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.
Maintain SOP and QS documents.
Collaborate with IT support to meet sponsor requirements.
Represent and support Clinical Monitoring teams with internal partners and external Sponsors to identify areas of improvement, address concerns, and integrate new technologies and processes.
Ensure regulatory compliance, industry best practices, and organizational goals and targets are met or exceeded.
Manage members of the Clinical Monitoring teams, ensuring adequate staffing with qualified personnel.
Provide ongoing support to staff in work allocation, resource planning, training and development, technology, process development, expense management, employee engagement, and performance management.
Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) Independent Contractor services, including needs assessment, recruitment, contract negotiations, policy compliance, training, cost monitoring, and performance management.
Provide expertise and develop tools to support project teams and business development in clinical, site, and compliance monitoring and performance.
Support the project life cycle from the bidding process through to reporting project findings to sponsors.