PSI CRO AG Looking for Clinical Trial Lead at Montreal, Quebec, Canada Full Time

PSI is a leading Contract Research Organization (CRO) with more than 25 years of experience in the pharmaceutical industry.

PSI is a privately-owned, full-service globally operating CRO. PSI’s global reach supports clinical trials across multiple countries and continents and we are known to be highly selective about the work we pursue. We focus on delivering quality and on-time services across a variety of therapeutic indications.

With an exceptionally high repeat and referral business rate combined with minimal staff turnover, PSI is committed to being the best CRO in the world as measured by its customers, employees, sites, and vendors.

Job Description

The Clinical Trial Lead role is a remote-based position.

As a Clinical Trial Lead, you will have the opportunity to take on a leadership role and supervise all clinical aspects of full-service, global projects. You will participate in the planning, implementation and management of projects in compliance with industry regulations, ICH-GCP and applicable controlled documents. You will assume responsibility for the coordination of the project team in designated countries and the monitoring of daily activities.

Responsibilities include:

• Manage clinical project timelines, milestones, schedules and updates during all project stages
• Manage and report on Key Performance Indicator (KPI’s); contribute to and participate in Project Review Meetings
• Ensure consistency of all study processes across regions (if delegated)
• Act as primary contact for the project team, i.e. CRAs, Project Assistants and PSI support services
• Be a point of contact for contractors and third party vendors
• Manage project teams in the region, including team building, quality compliance, training and monitoring of daily activities
• Contribute to the development and update of project planning documents, essential documents, and project instructions
• Oversee maintenance of study-specific and corporate tracking systems

Qualifications

• Relevant educational background, such as MD, MPharm, RN or university/college degree in Life Sciences or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities.
• Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor/Clinical Trial Lead and verified experience of supervised work in the capacity of Regional Lead role or equivalent.
• Full working proficiency in English
• Proficiency in MS Office applications
• Excellent communication, presentation and customer-service skills
• Strong ability to negotiate and build relationships at all levels
• Exceptional team building, leadership and organizational skills
• Ability to travel up to 25% (depending on project needs)
• Valid driver’s license (if applicable)

Additional Information

Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study.