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Study Startup Specialist II
PSI CROParis, Île-de-France, FranceIl y a 12 jours
Description de posteCollege / 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 Full working proficiency in English Welldeveloped communication and organizational skills Ability to negotiate and build relationships at all levels Excellent working conditions Extensive training and friendly team Competitive salary and benefits package Opportunities for personal and professional growth
Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
You will :
- Collaborate with the project team for site activation processes
- Assist in feasibility research and site identification
- Facilitate site agreement and budget negotiations
- Collect site documents for IRB / IEC submission and / or IPRED process
- Coordinate translation and review of studyspecific documents
- Identify and escalate projectspecific issues as needed
- Prepare and submit the study dossiers to sites competent authorities IRBs / IECs
- Prepare IPREDs packages
- Support initial distribution of Investigational Product(s) and clinical study supplies to sites
- Ensure exchange of information and documentation with investigational sites off site facilities and vendors
- Participate in development of sitespecific startup timelines and enrolment projections and is responsible for meeting the site activation targets
- Train and coach department staff on startup processes
Qualifications :
Additional Information :
We offer :
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.
Remote Work : Employment Type :
Fulltime
Key Skills
Sales Experience,Crane,Customer Service,Communication skills,Heavy Equipment Operation,Microsoft Word,Case Management,OSHA,Team Management,Catheterization,Microsoft Outlook Calendar,EHS
Experience : years
Vacancy : 1