• Serve as primary point of contact to study team on end-to-end start up activity
• Participate in or lead Study-Start-up team meetings as appropriate
• Utilize Study Start-Up tools to track activities and develop reports
• Oversee Feasibility activities including the negotiation and collection of Confidential Disclosure Agreements and management of Feasibility Tools
• Conduct site contract and budget negotiations (Confidentiality Agreement and Clinical Trial Agreements)
• Collect, track and review essential documents from sites and perform required quality reviews.
• Support the collection of country and site level intelligence
• Complete, manage and/or support Ethics Committee and Regulatory Authority submissions
• Where required, complete, manage and/or support country and site-specific activities (e.g., compiling, submitting and obtaining import/export licenses, radiation board and biobank committee approvals, etc.) required to activate sites for a clinical trial as appropriate

Qualifications (Minimal acceptable level of education, work experience, and competency):

• BA/BS degree in Science or related field
• Proficient in the English language
• Thorough understanding of clinical research principles and process
• At least 5 years experience in site start-up and contract management in pharmaceutical company or in clinical research organization
• Thorough knowledge of applicable regulations, drug development, and clinical trial management procedures
• Thorough understanding of ICH Guidelines and country/local regulatory requirements
• Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel
• Proficient in MS Office Suite (Outlook/Calendaring, Word, Excel, PowerPoint and Project), and strong email, presentation, documentation, and interpersonal skills
• Excellent oral and written communication skills