Study Startup Specialist II

Job summary

The Study Startup Specialist II will lead the study activation process on a country level, including site agreement and budget negotiations. They are responsible for collecting site documents, submitting dossiers to regulatory authorities, and ensuring project timelines are met.

Job details

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 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. Compensation: CAD 78000 - CAD 95000 - yearly

What you’ll do

The Study Startup Specialist II will lead the study activation process on a country level, including site agreement and budget negotiations. They are responsible for collecting site documents, submitting dossiers to regulatory authorities, and ensuring project timelines are met.

Requirements

Candidates must hold a college or university degree in Life Sciences and possess at least 2 years of full-scope study startup experience. Professional proficiency in both English and French is required for this role.

Benefits

• Competitive salary • Professional development • Training

Listed skills

• Project Coordination · Preferred
• Regulatory Compliance · Preferred
• Communication · Preferred
• Relationship Building · Preferred
• Contract Negotiation · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Study startup
• Clinical research
• Site activation
• Contract negotiation
• Budget negotiation
• IRB/IEC submission
• Document translation
• Regulatory compliance
• Project coordination
• Communication
• Organizational skills
• Relationship building
• Organizational Skills
• Bilingual (French/English)
• Medical Science
• Clinical Research
• Clinical Trials
• Contract Negotiation
• Life Sciences
• Negotiation
• Institutional Review Board (IRB)

Job areas

• Healthcare
• Science & Research
• Administrative
• Home Study Specialist
• Clinical Research Associate
• Biologists, Botanists, Zoologists and Related Professionals
• Clinical Research Coordinators
• Natural Sciences Managers