Study Startup Lead
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Take your career to the next level and be involved in study startup processes in China. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.
Office-Based: Shanghai
You will:
- Leads all study startup activities/processes with local project teams.
- In the absence of stand-alone feasibility function leads activities in feasibility research and site identification process.
- Oversees electronic Trial Master File (eTMF) maintenance during startup phase.
- Leads activities on negotiation of site agreement and/or budget to ensure alignment to the site activation plan.
- Reviews study-specific translations.
- Identifies project-specific issues and escalates to all functions concerned as outlined in the Project Communication Plan.
- Supervises preparation and/or submission of the study dossiers to sites to the competent authorities IRBs/IECs etc.
- Reviews IP-REDs packages.
- Oversees and reports on the site activation progress of the clinical sites.
- If qualified conducts site selection visits and/or functions as a field trainer for SSVs.
Qualifications :
- Bachelors or above degree in Pharmaceutical Medical Nursing and Life Sciences relevant major.
- At least 6 years of full-scope Study Startup experience in the country/region.
- Well-developed communication and organizational skills.
- Ability to negotiate and build relationships at all levels.
- Leadership mentoring and organizational skills
Additional Information :
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 :
No
Employment Type :
Full-time
Key Skills
- Administrative Skills
- Facilities Management
- Biotechnology
- Creative Production
- Design And Estimation
- Architecture
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
