Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.
Job Description
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
- 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
- Well-developed communication and organizational skills
- Ability to negotiate and build relationships at all levels
- Leadership, mentoring, and organizational skills