[Remote] Sr. Clinical Operations Lead (Clinical Trial Manager)

Note: The job is a remote job and is open to candidates in USA. Alimentiv is a company specializing in clinical services, and they are seeking a Senior Clinical Operations Lead to oversee clinical operations for projects at a regional or global level. The role involves managing project deliverables, providing training to Clinical Research Associates, and ensuring compliance with clinical standards and regulations.ResponsibilitiesOverall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelinesMonitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned aboveMay support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)Oversee regional startup and feasibility activitiesAssist in vendor management activities as required per projectPerform review of visit reports for quality, compliance and appropriate site managementAssure compliance with high quality and timely project deliverables according to the project requirements and the monitoring planProactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progressContribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense reviewMay be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basisConduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA callsAttend meetings with Study Sponsor to provide status updates on country and site progressProvide operational support and guidance to the monitoring team throughout projectProvide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study. Ensures study specific training requirements are completed and documentedFirst point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriateSupport line managers by providing status updates on utilization and performance of CRAsLiaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the projectConduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilitiesDevelop training materials and study tools for sites and CRAs, including monitoring plansDevelop and implement enrolment and recruitment strategies together with clinical project teamDevelop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation VisitsSkillsCollege diploma/degree AND 7-9 years related experience + continuous training and knowledge/skills upgradingORUndergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related trainingShould have a minimum of 3 years CRA experienceHave strong experience with EDC systemsBe proficient with MS OfficeHave strong written and verbal communication skillsHave highly effective interpersonal and organizational skillsDemonstrate the following attributes: proactive, detail oriented, task-driven and highly organizedDemonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilitiesDemonstrated ability in report writing and strong ability to critically understand clinical research documentsAbility to handle multiple tasks to meet deadlines in a dynamic environmentHealth Sciences, Life Sciences or Nursing specialty preferredSoCRA and/or ACRP Certification/DesignationCompany 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/.