Full-Time 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.

1. Collaborate with the project team for site activation processes
2. Assist in feasibility research and site identification
3. Facilitate site agreement and budget negotiations
4. Collect site documents for IRB/IEC submission and/or IP-RED process
5. Coordinate translation and review of study-specific documents
6. Identify and escalate project-specific issues as needed
7. Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
8. Prepare IP-REDs packages
9. Support initial distribution of Investigational Product(s) and clinical study supplies to sites
10. Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
11. Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets
12. Train and coach department staff on startup processes

Requirements:

• 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 UK
• Well-developed communication and organizational skills
• Ability to negotiate and build relationships at all levels

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