[Remote] Director, Clinical Trial Management

Note: The job is a remote job and is open to candidates in USA. Alimentiv is a global CRO focused on advancing therapies for gastrointestinal diseases. The Director of Clinical Trial Management is responsible for the leadership and operational oversight of the Clinical Monitoring unit, ensuring high-quality clinical trial execution and compliance across global studies.ResponsibilitiesWorking 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 basisRepresent 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 processesEnsure regulatory compliance, industry best practices, and organizational goals and targets are met and/or exceededManage 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)Identify, procure, and manage Clinical Monitoring (Clinical Operations Leads) 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 maintainedProvide 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 sponsorsSkillsCollege 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 trainingExperience in managing CRA staff and ability to provide training and/or mentorship to colleagues on a 1:1 basis or meeting settingAbility to work in a remote global capacityStrong knowledge of appropriate regulations and guidelines as they pertain to clinical monitoring and GCPTeam player that has a customer service approach and is solution orientedDemonstrated leadership skillsStrong verbal, written, and organizational skillsAbility to handle multiple tasks to meet deadlines in a dynamic environmentCompany OverviewIndustry-leading specialty GI contract research organization (CRO) transforming clinical trial outcomes and accelerating the development of life-changing therapies. It was founded in 1986, and is headquartered in London, Ontario, CAN, with a workforce of 501-1000 employees. Its website is https://alimentiv.com/.