Study Startup Specialist II/I at PSI CRO

Daxing District, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

0.0

Posted On

10 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Communication, Organizational Skills, Negotiation, Relationship Building, Leadership, Mentoring, Site Startup Experience, Regulatory Document Collection, Budget Negotiation, Project Coordination, Timeline Development, Enrollment Projections, Trial Master File Maintenance, Study Activation, Fluent English, Fluent Japanese

Industry

Pharmaceutical Manufacturing

Description

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 3000 driven, dedicated and passionate individuals. We work on the front-line 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 Base: Shanghai/Beijing 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 Bachelor's degree of Medical, Pharmaceutical or any Life Sciences related major At least 2 years site startup experience Well-developed communication and organizational skills Ability to negotiate and build relationships at all levels Leadership, mentoring, and organizational skills English and Japanese skills (High Business level to Fluent) Additional Information Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company, that puts its people first!

Responsibilities

Lead the study activation process on a country/regional level, ensuring projects start smoothly and on time. Communicate with project teams and investigational sites throughout the study startup phase.