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Study Startup Specialist II

Job Description - Study Startup Specialist II

Company Description

PSI is a leading Contract Research Organization with more than 28 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

Job Description: 

  • Coordinates study startup activities critical for site activation​
  • Supports Feasibility department​
  • Facilitates site agreement and/or budget negotiations​
  • Collects site documents for IRB/IEC submission and/or IP-RED process​
  • Coordinates translation and reviews​
  • Support initial distribution of Investigational Product(s) and clinical study supplies to sites
  • Under supervision prepares and submits the study dossiers to sites, competent authorities, IRBs/IECs, Prepares IP-REDs packages. ​
  • Support study supplies distribution to sites ​

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training and experience
  • At least 2 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

Additional Information

We offer:

  • Excellent working conditions
  • Extensive training and friendly team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth

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.

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