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Clinical Operations Lead

March 12

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Alimentiv

Learn about career opportunities, our culture, and our mission to improve human health.

Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management

201 - 500

Description

• Responsible for clinical operations of a project within a defined regional/global level • Provides oversight of project deliverables, CRAs, and Investigator sites • Acts as a primary liaison between CRAs and the clinical project team • Develops study tools for site and CRA use • Conducts assessment visits with CRAs • Oversees monitoring visit scheduling, site and monitoring performance metrics • Develops and implements enrollment and recruitment strategies • Prepares monitoring plan and other structural documentation • Supports clinical operations and the clinical project team • Provides oversight of study deliverables related to other departments • Assists in vendor management activities • Develops training materials and study tools for sites and CRAs • Conducts CRA Assessment visits • Provides project training/mentoring to regional CRAs • First point of contact for regional CRAs for study-specific questions and issues

Requirements

• 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 • Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation • Minimum of 3 years CRA experience • Strong experience with EDC systems • Proficient with MS Office • Strong written and verbal communication skills • Highly effective interpersonal and organizational skills • Proactive, detail oriented, task-driven, and highly organized • Demonstrated understanding of GCPs and local regulations • Ability to handle multiple tasks to meet deadlines

Benefits

• Home-based working • Accommodations for persons with disabilities available upon request

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