Role overview

Qualifications

College/University degree in Life Sciences or equivalent
At least 2 years of full-scope Study Startup experience
Full professional working proficiency in English and French
Well-developed communication and organizational skills

Responsibilities

Collaborate with 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

Key facts

Remote from: Canada
Full time
Mid-level (2-5 years)
English, French

Hard skills

Clinical Research

Other skills

Communication
Organizational Skills
Negotiation
Relationship Building

About the company

PSI CRO AG

Pharmaceuticals

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. http://www.psi-cro.com

Company details

Company typeLarge

IndustryPharmaceuticals

Company size1001 - 5000

Links

Website LinkedIn See all jobs

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Job description

Company Description

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.