Study Startup Specialist II

Role Summary

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.

Requirements

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
• 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

Benefits

• 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.

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.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

About the Company

Why Join PSI?

At PSI, we believe exceptional people deserve an exceptional workplace.

When you join PSI, you'll benefit from

A stable, privately held CRO that has never undergone a merger or acquisition and has never experienced company-wide layoffs.

A unique leadership-focused CRA role with minimal travel and little to no routine site assignments.

Opportunities to mentor other CRAs and expand your leadership skills.

A collaborative, people-first culture where employees are genuinely supported.

Career development opportunities across a growing global organization.

The chance to contribute to innovative clinical research that improves patients' lives.

We are the company that cares - for our staff, our clients, our partners, and the quality of the work we do.

Founded in 1995, PSI CRO is a privately owned, global Contract Research Organization with more than 3,000 employees dedicated to advancing medical science and bringing new therapies to patients worldwide.

In an industry shaped by mergers, acquisitions, and restructures, PSI stands apart. We have remained privately held, have never undergone a merger or acquisition, and have never experienced company-wide layoffs. Our long-term stability allows us to invest in our people, foster meaningful careers, and build lasting partnerships with our clients.

If you're looking for a collaborative organization where you can continue to grow while making a meaningful impact, PSI is the right place for you.