Vacancy expired!
Sr Clinical Trial ManagerPlan, manage and oversee trials including internal and external staff. Responsibility for CRO oversight. Train, coordinate and performance reviews on direct reports.Responsibilities :Manage clinical trials that are conducted through CRO’s including performance assessmentAct as facilitator, set agendas, study team meetingsPrimary contact for vendorsResponsible for protocol execution of trialsInteract cross functionally with other departments within the organization such as Regulatory Affairs, Drug Safety, etc.May help in development of study protocols, ICF, CRF and other study/monitoring toolsEstablish, track and report of study metricsResponsible for Trip Report Review, TMF review, co-monitoring visits and provide documentation of all issues and findingsCo-monitor sites with up to 25% travelPre-visit site selection, site initiation visit, interim monitoring visit and close out visitsAssist with other vendor types such as labsProtocol operational feasibility assessmentAssist in preparation for regulatory inspectionsReview IRB approved informed consent formsStudy guide and subject instruction preparationEnsure compliance with policies and SOP’sMay assist with preparation of study reports, IND safety and clinical summariesMay supervise staffRequirements :BA/BS in biological sciences or related field9 years in biotech/pharma industry with 4 years in clinical operations including knowledge of regulations and guidelinesExpertise in clinical development studiesPreparation of IND, BLA or NDAManagement of multinational clinical trialsExperience in all phases of drug development, including international trialsWhy Kelly ® ?With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Vacancy expired!