[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.

Responsibilities

• Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines
• Monitoring support visits (Co-monitoring), per project requirements, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above
• May 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 activities
• Assist in vendor management activities as required per project
• Perform review of visit reports for quality, compliance and appropriate site management
• Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan
• Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.) and inform clinical project team on progress
• Contribute 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 review
• May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis
• Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
• Attend meetings with Study Sponsor to provide status updates on country and site progress
• Provide operational support and guidance to the monitoring team throughout project
• Provide 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 documented
• First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate
• Support line managers by providing status updates on utilization and performance of CRAs
• Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project
• Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities
• Develop training materials and study tools for sites and CRAs, including monitoring plans
• Develop and implement enrolment and recruitment strategies together with clinical project team
• Develop 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 Visits

Skills

• College diploma/degree AND 7-9 years related experience + continuous training and knowledge/skills upgrading
• OR
• Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
• Should have a minimum of 3 years CRA experience
• Have strong experience with EDC systems
• Be proficient with MS Office
• Have strong written and verbal communication skills
• Have highly effective interpersonal and organizational skills
• Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized
• Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities
• Demonstrated ability in report writing and strong ability to critically understand clinical research documents
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• Health Sciences, Life Sciences or Nursing specialty preferred
• SoCRA and/or ACRP Certification/Designation

Company Overview