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PSI
Study Startup Specialist II.PSI • Mississauga, ON, CA
Study Startup Specialist II.

Study Startup Specialist II.

PSI • Mississauga, ON, CA
25 days ago
Job type
  • Full-time
Job description

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:

  • Collaborate with the project team for site activation processes
  • Facilitate site agreement, contract negotiations and budget negotiations
  • Collect site documents for IRB/IEC submission and/or IP-RED process
  • Coordinate translation and review of study-specific documents
  • 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

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.
  • Full professional working proficiency in English and French.
  • 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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Study Startup Specialist II. • Mississauga, ON, CA

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