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.
You will:
- Maintains studyspecific 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
- 23 years prior clinical study and site startup experience
- Welldeveloped 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 :
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
