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 activationCoordinates activities in feasibility research and site identification process in support to Feasibility DepartmentFacilitates 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 processCoordinates study-specific documents for translation and reviews study specific translationIdentifies project-specific issues and escalates to Regional (Startup) Lead/PM and operational Manager in the countryUnder supervision prepares and submits the study dossiers to sites, competent authorities, IRBs/IECsPrepares IP-REDs packagesSupports 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 phaseParticipates in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targetsSupports training of department staff in matters related to study startup processesProvides on-the-job coaching of local department staff

QualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training and experienceAt least 2 years of full-scope Study Startup experience in the country/regionWell-developed communication and organizational skillsAbility to negotiate and build relationships at all levelsLeadership, mentoring, and organizational skills

Additional Information

Advance your career in clinical research, overseeing a variety of tasks and growing with the company. You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects.

Excellent working conditionsExtensive training and friendly, collegial teamCompetitive salary packageOpportunities for personal and professional growth