Study Startup / Site Activation Specialist - Temporary position

  • Full-time

Company Description

PSI is a leading Contract Research Organization with more than 30 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

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 mainly: 

  • Lead finalization of site/vendor agreements and budgets negotiation to ensure alignment to the study activation plan
  • Customizes and prepare country- site-specific and vendor agreements and agreement amendments
  • Prepare and track the status of site and vendor agreements, budget negotiation, and coordinates the signature process

Additionally, you will:

  • Coordinates study startup activities with the local project team and supports all processes critical for site activation.
  • Collaborate with the project team for site activation processes
  • Assist in feasibility research and site identification
  • Collect site documents for IRB/IEC submission and/or IP-RED process
  • Identify and escalate project-specific issues as needed
  • Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
  • Prepare IP-REDs 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 site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets
  • Train and coach department staff on startup processes

 

***Note, this is a temporary position for a period of 6-10 months***

 

Qualifications

  • ​​​​College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • 2+ years of full-scope Study Startup experience in the country/region
  • Full working proficiency in Hebrew and English
  • Proficiency in MS Office applications
  • Ability to negotiate and build relationships at all levels
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Attention to detail, organizational and time-management skills

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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