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

Employment type
Full-time

Work arrangement
Hybrid