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