Manager, Monitoring – Site Management

This is a fully remote position, open to applicants in North Carolina, +4 more states.

📋 Description

• Oversee, coordinate, and assess the daily operations of the Clinical Monitoring unit through planning and management.

• Enhance and refine existing policies and procedures.

• Supervise product quality, site performance, and compliance standards.

• Allocate and manage staff resources while evaluating the performance of both staff and contractors.

• Provide support and expertise, representing project and clinical monitoring teams in collaboration with sponsors and researchers throughout the project lifecycle.

• Ensure that team members and external providers deliver services that are high in quality and timely, adhering to corporate standards and regulatory guidelines.

• Identify, develop, plan, monitor, approve, and/or report on processes and services specific to projects, including site selection, clinical monitoring, resolution of ICH-GCP compliance issues, global project alignment, SOP and QS document management, periodic site visits, and IT collaboration.

• Act as a representative and supporter of Clinical Monitoring teams with internal partners and external sponsors to pinpoint enhancements, resolve issues, and implement new technologies and processes.

• Manage Clinical Monitoring team staffing, task distribution, resource planning, training and development, technology integration, process advancements, expense oversight, employee engagement, and performance evaluations.

• Identify, source, and oversee independent contractor services for Clinical Monitoring, covering needs assessment, recruitment, contract negotiation, policy adherence, training, cost monitoring, and performance assessment.

• Create tools to assist project teams and business development in clinical, site, and compliance monitoring from the bidding phase through to reporting findings to sponsors.

⛳️ Requirements

• College Diploma or University Degree in a relevant field (preferably Health Sciences or Life Sciences), or SoCRA and/or ACRP Certification/Designation.

• A minimum of 4-6 years of relevant experience along with significant ongoing training.

• Experience in managing CRA staff.

• Capability to provide training and mentorship to colleagues individually or in group settings.

• Ability to operate effectively in a remote global environment.

• Strong understanding of regulations and guidelines related to clinical monitoring and GCP.

• Customer service-focused and solution-driven mindset.

• Proven leadership abilities.

• Excellent verbal, written, and organizational skills.

• Ability to manage multiple tasks and adhere to deadlines in a fast-paced environment.

🏝️ Benefits

• Bonus

• Home-based/remote work