As a Senior Site Activation Manager, you will play a critical leadership role in advancing clinical research by driving site activation strategies and study start-up activities across assigned therapeutic areas. You will serve as a key partner to sponsors, project teams, investigators, and cross-functional stakeholders, overseeing site activation deliverables, managing critical timelines, mitigating risks, and providing strategic guidance. This is a REMOTE role open to candidates based in Remote, collaborating with global teams across multiple time zones.
Responsibilities
Lead and oversee study start-up and site activation activities, serving as the primary point of accountability for assigned projects; Drive cross-functional collaboration to ensure critical site activation milestones and deliverables are completed on time and within budget; Manage and analyze site activation metrics, identifying risks and implementing mitigation plans to support study success; Partner with project teams to accelerate site qualification, selection, regulatory, and essential document collection activities; Communicate project status, timelines, risks, and outcomes to sponsors, project leadership, and internal stakeholders; Ensure site activation activities are accurately tracked, budgeted, and maintained in accordance with project requirements and change management processes; Contribute to proposals, budgets, bid defense activities, and other business development initiatives related to site activation; Coach and mentor Site Activation Managers while supporting the development of SOPs, best practices, and continuous process improvement efforts; Ensure compliance with ICH GCP, applicable regulations, SOPs, and study-specific requirements throughout the site activation lifecycle
Requirements
Bachelor's degree in a medical, biological, physical, health, pharmacy, or related science field, or a two-year degree plus four years of clinical research experience; Seven or more years of CRO and/or pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management; Strong leadership, organizational, and project management skills with the ability to manage multiple priorities and deadlines; Thorough understanding of site activation processes, clinical project planning and execution, and country- or region-specific regulatory requirements; Strong knowledge of ICH GCP guidelines, FDA/EU Clinical Trials Directives, and national regulatory requirements; Demonstrated ability to make independent decisions, solve complex problems, and effectively manage risk in a fast-paced environment; Excellent collaboration, communication, mentoring, and stakeholder-management skills with experience working across global and cross-cultural teams; Proficiency in spoken and written English
Benefits
Competitive benefits package depending on location
Stany Zjednoczone · Durham
