Manager, Monitoring & Site Management
New
A
AlimentivClinical research
Workplace type: Remote; Listing location: Raleigh-Durham, North Carolina / Atlanta, Georgia / Boston, Massachusetts / Philadelphia, Pennsylvania / Minneapolis, Minnesota / Nashville, TennesseeFull-TimeManager
Salary$110,500 - $174,000 a year + bonus
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Job Details
- Experience
- A minimum of 4-6 years related experience
- Required Skills
- Resource Planning
Requirements
- Hold a College Diploma or University Degree in a relevant field; Health Sciences or Life Sciences is preferred, or have SoCRA and/or ACRP Certification/Designation.
- Have a minimum of 4–6 years of related experience and substantial ongoing training.
- Have experience managing CRA staff.
- Be able to provide one-to-one or group training and mentorship to colleagues.
- Have strong knowledge of regulations and guidelines related to clinical monitoring and GCP.
- Demonstrate leadership skills.
- Bring a customer-service approach and a solution-oriented mindset.
- Have strong verbal, written, and organizational skills.
- Be able to manage multiple tasks and meet deadlines in a dynamic environment.
- Be able to work in a remote global capacity.
Responsibilities
- Plan, manage, organize, evaluate, and report on delivery of the Clinical Monitoring unit.
- Develop and improve policies, processes, tools, and project-specific services for clinical monitoring.
- Coordinate site selection, ICH-GCP compliance issue resolution, project harmonization, SOP and QS document maintenance, and periodic site visits.
- Represent Clinical Monitoring teams with internal partners, sponsors, researchers, and project teams throughout the project life cycle.
- Address sponsor and site concerns and identify opportunities to improve service delivery and integrate new technologies and processes.
- Manage staff work allocation, resource planning, training and development, engagement, and performance management.
- Identify, procure, and manage independent contractor services, including recruitment, contract negotiations, training, cost monitoring, and performance management.
- Provide clinical, site, and compliance monitoring expertise to project teams and business development from bidding through reporting findings to sponsors.
- Ensure staff and third-party providers deliver timely, high-quality services that meet regulatory requirements and guidelines.
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