Study Startup Specialist II
Study Startup Specialist II
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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 IPRED process
- Coordinates studyspecific documents for translation and reviews study specific translation
- Identifies projectspecific 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 IPREDs 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 sitespecific 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 onthejob 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 fullscope Study Startup experience in the country/region
- Welldeveloped 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 crossfunctional teams get all support and ownership of your projects.
- Excellent working conditions
- Extensive training and friendly collegial team
- Competitive salary package
- Opportunities for personal and professional growth
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
