Manager, Monitoring & Site Management
Manager, Monitoring & Site Management
Posted on :
03-06-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
03-06-2025
Job Description
Responsible to plan manage organize evaluate and/or report on the day delivery of the Clinical Monitoring unit. Role includes policy and process development and improvement 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.
Project Planning
- 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.
Customer Service Delivery
- 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.
Team Management and Engagement
- 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).
Third Party Contract 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.
Product/Service Delivery Support
- 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.
Qualifications
- The successful candidate should have a College Diploma/University Degree in a relevant field (Health Sciences Life Sciences preferred or SoCRA and/or ACRP Certification/Designation) and a minimum of 4-6 years related experience substantial on-going training.
- Experience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or 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 that has a customer service approach and is solution oriented.
- Demonstrated leadership skills
- Strong verbal written and organizational skills.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Working Conditions
- Home-based
$110500 - $184000 a year
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Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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