Study Startup Specialist II

Overview

In this role you lead country‑level study activation, ensuring startups run smoothly and projects begin on schedule. You support clinical teams and help manage startup processes, site documents, and IP‑RED procedures. You coordinate timelines, feasibility insights, and vendor communications to keep trials on track. You work closely with cross‑functional teams in a people‑focused environment that values development and impact. This is an opportunity to shape study activation at scale while advancing patient‑centered research.

Pay / Benefits

• Excellent working conditions
• Extensive training and friendly team
• Competitive salary and benefits package
• Opportunities for personal and professional growth

Responsibilities

• Perform study startup activities and support processes critical for site activation
• Collect site documents for IRB/IEC submission and/or IP-RED process
• File study-specific documentation in TMF per management plan
• Assist in feasibility research and site identification
• Facilitate site agreement and budget negotiations
• Coordinate translation and review of study-specific documents
• Identify and escalate project-specific issues
• Prepare and submit IP-RED packages
• Ensure initial distribution of local and central study supplies to sites
• Maintain information exchange with investigational sites, off-site facilities and vendors
• Contribute to development of site-specific startup timelines and enrolment projections and meet activation targets

Key requirements

• College/University degree in Life Sciences or equivalent combination of education, training and experience
• At least 2 years of full-scope Study Startup experience in the country/region
• Full working proficiency in English
• Well-developed communication and organizational skills
• Ability to negotiate and build relationships at all levels

• communication
• organization
• negotiation
• study startup
• IP-RED
• TMF

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