Study Startup Specialist II

Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time. 

You will: 

• Perform study startup activities and support all processes critical for site activation
• Collect site documents for IRB/IEC submission and/or IP-RED process
• File study-specific documentation in TMF, in accordance with Document management plan
• Assist in feasibility research and site identification, upon request
• Facilitate site agreement and budget negotiations
• Coordinate translation and review of study-specific documents
• Identify and escalate project-specific issues as needed
• Prepare and submit IP-REDs packages
• Ensure initial distribution of locally obtained clinical study supplies to sites and supervises initial distribution of Investigational Product(s) and centrally obtained clinical study supplies to sites
• Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
• Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets under supervision

• College/University degree in Life Sciences or an 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

We offer:

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

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.