Study Startup Manager
Study Startup Manager
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Job Description
Take your career to the next level and manage clinical study startup activities in Japan. You will share your expert knowledge develop clinical project startup strategies provide operational support and ensure that PSI projects start smoothly and on time.
This position can be located in Tokyo or Osaka.
(Hybrid work)
You will:
- Lead and manage all clinical study startup activities/processes with local project teams
- Develop startup strategies and oversee startup activities in Japan
- Participate in development and update of project/country startup and site activation timelines. Ensures that startup deliverables in assigned country are met.
- Lead and facilitate activities on negotiation of site agreement and/or budget to ensure alignment to the site activation plan
- Supervise preparation and/or submission of the study dossiers to sites to the competent authorities IRBs/IECs etc.
- Communicates with the project team and investigational sites throughout the study startup phase
- May review study specific translations
- Monitor and evaluate operational resources involved in startup activities
- Manage and train startup team members
- 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.
Qualifications :
- 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 in Japan
- Welldeveloped 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 Japanese and English languages both written and verbal
- Indepth knowledge of ICHGCP guidelines and Japanese regulatory requirements
- Demonstrated ability to manage multiple projects simultaneously and meet tight deadlines
- Strong problemsolving skills and ability to work independently in a fastpaced environment
Additional Information :
How are we different
PSI is privately owned by the very people who founded the company more than 25 years ago and theyre still working here today. As a result we have grown organically around the globe and have kept our company fully independent giving us significant advantages and freedoms.
Being a Part of the Team
As a part of the PSI team you will have a fair degree of ownership and autonomy to make nuanced countryand departmentspecific adjustments while nurturing the global PSI culture that unites us across six continents.
You will receive continuous support from your global peers and join a fastpaced innovative and resultsoriented working environment with lean communication lines. We pride ourselves on being approachable receptive to new ideas and open to feedback.
Growth Opportunities
PSI is proud to invest in our people from entrylevel team members to senior leaders helping you identify and hone your unique strengths at every step of your career. From onthejob learning experiences to formal development programs our professionals have a variety of opportunities to continue to grow throughout their career.
PSI is an inclusive and equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
