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

Office based in Shanghai

You will:
- Coordinates study startup activities with the local project team and supports all processes critical for site activation.
- Coordinates activities in feasibility research and site identification process in support to Feasibility Department.
- Facilitates site agreement and/or budget negotiations with sites to ensure alignment to the site activation plan.
- Collects site documents for IRB/IEC submission and/or IP-RED process.
- Coordinates study-specific documents for translation and reviews study specific translation.
- Identifies project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the country.
- Under supervision prepares and submits the study dossiers to sites, competent authorities, IRBs/IECs.
- Prepares IP-REDs packages.
- Supports initial distribution of Investigational Product(s) and clinical study supplies to sites.
- Ensures exchange of information and documentation with investigational sites, off site facilities and vendors throughout study startup phase.
- Participates in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets.
- Supports training of department staff in matters related to study startup processes.
- Provides on-the-job coaching of local department staff.

Qualifications

- At least Bachelor's degree in Pharmaceutical, Medical, Nursing and Life Sciences relevant major.
- At least 1 year of full-scope Study Startup experience in the country/region.
- Well-developed communication and organizational skills.
- Ability to negotiate and build relationships at all levels.
- Leadership, mentoring, and organizational skills.