Study Startup Specialist II

PSI CRO; Mississauga; Hybrid; CAD 65,000 - 85,000; Full time

Benefits offered by this job

Excellent working conditions

Extensive training

Competitive salary

Benefits package

Opportunities for growth

Job summary

PSI CRO is looking for a dedicated individual to lead clinical study activation processes at a country level. You will ensure that projects start smoothly and on time while collaborating with project teams and facilitating necessary site agreements.

A degree in Life Sciences and at least 2 years of Study Startup experience, along with full proficiency in English and French, are required. The role offers excellent working conditions and opportunities for personal and professional growth.

Qualifications

• At least 2 years of full-scope Study Startup experience.
• Full professional working proficiency in English and French.

Responsibilities

• Collaborate with the project team for site activation processes.
• Facilitate site agreement and contract negotiations.
• Collect site documents for IRB/IEC submission.
• Coordinate translation of study-specific documents.
• Elevate project-specific issues as needed.
• Prepare and submit the study dossiers to sites and authorities.
• Prepare IP-REDs packages.
• Support distribution of Investigational Product(s).
• Ensure exchange of information with investigational sites.
• Participate in development of site-specific startup timelines.

Skills

Communication skills

Organizational skills

Negotiation

Bilingual (English & French)

Education

College/University degree in Life Sciences

Job 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.

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 elevate 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

• 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.