PSI CRO

Study Startup Lead

PSI CRO  •  Shanghai, CN (Onsite)  •  2 hours ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description

Company Description

We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

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.

PSI CRO

About PSI CRO

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 effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.

PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.

PSI’s reputation is that of a 'no-nonsense'​ CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.

http://www.psi-cro.com

Industry
Chemicals & Materials
Company Size
1,001-5,000 employees
Headquarters
Zug, CH
Year Founded
Unknown
Social Media