Study Startup Specialist II

Psi CRO; Mississauga; On-site; CAD 78,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

Extensive training

Friendly team

Health benefits

Job summary

Psi CRO in Mississauga, Canada, is seeking a Study Startup Lead to manage country-level site activation, agreements, and timelines. You will collaborate with project teams to ensure timely study startup and smooth project initiation.

Requires a Life Sciences degree and at least 2 years in Study Startup, plus strong English and French communication and negotiation skills; offers excellent working conditions, extensive training, and opportunities for personal and professional growth.

Qualifications

• College/University degree in Life Sciences or equivalent.
• At least 2 years of full-scope Study Startup experience.
• Strong English and French language skills and excellent communication.

Responsibilities

• 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.
• 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 be responsible for meeting the site activation targets.

Skills

English proficiency

French proficiency

Negotiation

Communication

Relationship building

Education

College/University degree in Life Sciences

Job description

• Compensation: CAD 78,000 - CAD 95,000 - yearly

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 escalat project-specific issues as needed
• Prepareand submitthe study dossiers to sites, competent authorities, IRBs/IECs
• Supportinitial distribution of Investigational Product(s) and clinical study supplies to sites
• Ensureexchange of information and documentation with investigational sites, off site facilities and vendors
• Participatein 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 2years 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.