Study Startup Associate

PSI CRO

Shanghai , China

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:

Maintains study-specific and corporate startup tracking systems
Facilitates site budgets and contract negotiations
Supports site regulatory document collection
Under supervision, may prepare initial submission dossiers to competent authorities, ethics committees, and/or site submission dossiers (as applicable)
Communicates with the project team and investigational sites throughout the study startup phase
Develops site specific startup timelines and enrollment projections and is responsible for meeting the site activation milestones
May review study specific translations
Supervises Trial Master File (TMF) maintenance throughout the study startup phase

Qualifications

College/University degree in Life Sciences or an equivalent combination of education, training and experience
At least 18 months prior clinical study and site startup experience
Well-developed communication and organizational skills
Ability to negotiate and build relationships at all levels
Leadership, 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.