Study Startup Specialist II

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

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

We offer:

Excellent working conditions

Extensive training and friendly team

Competitive salary and benefits package

Opportunities for personal and professional growth

For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.

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.