Study Startup Specialist Jobs in Mississauga, Ontario, Canada
Create alert for “Study Startup Specialist”
Mississauga, Ontario, Canada
Top Benefits
About the role
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.
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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About PSI CRO AG
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.