Study Startup Lead

PSI CRO AG · Shanghai, China · full-time · On site · yesterday

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Posted October 12, 2026 · Read from PSI CRO
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Job Description

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.

This role is office-based in 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

  • Bachelor's 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.

Employer
PSI CRO AG
Location
Shanghai, China · On site
Contract
full-time