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 2,500 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.

Job Description

In this role, you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level.

Only CVs in English will be considered.

You will:

Facilitate regional projects as Lead Monitor and supervise study activities, timelines and schedules
Train Monitors in annotated monitoring visit reports
Review monitoring reports and support monitors in their activities
Act as the main communication line between Monitor and Regional Lead
Facilitate site budgets and contract negotiations
Be a point of contact for in-house support services and vendors
Communicate with internal project teams regarding study progress and lead project team calls on the country level
Participate in quality control and compliance monitoring
May need to monitor and manage sites (if applicable)
May need to supervise monitors on site
Oversee and maintain study-specific and corporate tracking systems at site and country level

Qualifications

College/University degree in Life Sciences, Pharmacy or an equivalent combination of education, training & experience
Participation in clinical projects as a Lead/Senior Monitor
At least 4 years of experience as Senior CRA
Independent on-site monitoring experience
Full working proficiency in English and Spanish
PC skills to be able to work with MS Word, Excel and PowerPoint
Ability to plan, multitask and work in a dynamic team environment
Communication, leadership, and problem-solving skills
Ability to travel

Additional Information

Advance your career in clinical research, overseeing a variety of tasks and growing with the company. You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects.

Lead CRA