Site Activation Manager

• Serve as the primary point of communication and accountability for study start-up and maintenance activities
• Oversee functional group activities involved in site activation to ensure critical-path activities are completed on time and within budget
• Compile, manage, track, and analyze site activation activities
• Support feasibility and site identification activities as needed
• Expedite Site Qualification and Selection processes
• Communicate Site Activation and Regulatory project status to sponsors and project teams
• Prepare risk assessments and mitigation plans
• Ensure study activities are included in work order budgets and track out-of-scope activities through change orders
• Develop and maintain site activation project plans
• Contribute to SOPs, best-practice guidelines, training, and coaching
• Provide input to departmental process improvement initiatives
• Establish and interpret site activation metrics to drive corrective action and achieve KPIs
• Support business development through proposals and bid defense meetings
• Report and escalate issues to leadership to resolve risks and protect deliverables
• Comply with SOPs, ICH GCP, and applicable regulations
• Liaise with functional contributors and vendors
• Perform other duties as assigned

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs)
• Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience
• Proficient in cross-cultural communication
• Proficient in both spoken and written English
• Strong leadership and organizational management skills
• Ability to exercise sound judgment and make decisions independently
• Ability to motivate, lead and engage a team
• Strong interpersonal, oral, and written communication skills
• Understanding of regulatory processes and guidelines
• Understanding of initiation, planning, and execution of clinical projects and overall project planning
• Awareness of ICH GCP Guidelines and FDA/EU Clinical Trials Directives/National regulations
• Ability to handle multiple tasks in a fast-paced and constantly changing environment
• Ability to work in an organized, methodical, and self-motivated manner
• Proficiency in Microsoft Word, Excel, PowerPoint, and digital systems

• Equal employment opportunity employer
• Diverse and inclusive work environment
• Collaboration and creativity-focused workplace