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Job Description
- Req#: REF3171J
- Develop startup strategies and oversee startup activities in the region
- Lead and manage all clinical study startup activities/processes with local project teams
- Monitor and evaluate operational resources involved in startup activities
- Manage and train startup team members
- Provide study startup updates to Project Managers and Country Heads
- Facilitate cooperation between cross-functional teams regarding startup activities
- Support operational teams in feasibility research, site identification and selection
- Oversee study submissions to competent authorities, ethics committees, and other review bodies
- Oversee preparation of documents for drug release to clinical sites and entire site activation process
- Oversee site contracting activities
- Develop and update manuals, local instructions, and user guides relevant to Study Startup activities within the assigned country and provides local expertise and best practices to other PSI functions and clients.
- College/University degree in Life Sciences or an equivalent combination of education, training and experience
- Minimum of 7 years prior clinical study and site startup experience
- Well-developed communication and organizational skills
- Experience in leadership managing people
- Ability to negotiate and build relationships at all levels
- Leadership, mentoring, and organizational skills
- Experience as a Senior CRA, Clinical Trial Lead or Project Manager is a plus
- Proficiency in Chinese and English languages, both written and verbal
- Demonstrated ability to manage multiple projects simultaneously and meet tight deadlines
- Strong problem-solving skills and ability to work independently in a fast-paced environment
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.
Job Description
Take your career to the next level and manage clinical study startup activities in China. You will share your expert knowledge, develop clinical project startup strategies, provide operational support and ensure that PSI projects start smoothly and on time.
Based in Shanghai
You will:
Qualifications
About the company
PSI is a leading full-service global Contract Research Organization. Predictable patient enrollment across multiple therapeutic areas.
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