Alimentiv is hiring a
Manager Clinical Operations in Netherlands, United Kingdom

Summary

The Manager of Clinical Operation Leads (Manager COLs) will manage the Clinical Operation Leads and oversee clinical trial operational activities. Responsibilities include planning, managing, organizing, evaluating, reporting on day-to-day delivery of the Clinical Monitoring unit, policy and process development, customer service delivery, team management and engagement, third party contract management, and product/service delivery support. The ideal candidate should have a College Diploma/University Degree in a relevant field with 4-6 years related experience.

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
• Previous experience as a Clinical Study Manager (CTM), Clinical Operation Lead or Clinical Project manager
• Experience in managing 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

Responsibilities

• Plan, manage, organize, evaluate and/or report on the day delivery of the Clinical Monitoring unit
• 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
• 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

Benefits

Home-based