Study Startup Specialist II

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. Compensation: CAD 78000 - CAD 95000 - yearly

Lead the study activation process at a country level to ensure clinical research projects start smoothly and on time. This includes managing site agreements, contract negotiations, and the submission of study dossiers to regulatory authorities.

Requires a degree in Life Sciences or equivalent experience and at least 2 years of full-scope Study Startup experience. Full professional proficiency in both English and French is mandatory.

• Competitive Salary • Benefits Package • Extensive Training • Professional Growth Opportunities

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Site Activation
• Contract Negotiation
• Budget Negotiation
• IRB/IEC Submission
• Document Coordination
• Study Dossier Preparation
• IP-RED Process
• Clinical Study Supplies Distribution
• Timeline Development
• Enrolment Projections
• English Proficiency
• French Proficiency
• Communication Skills
• Organizational Skills
• Relationship Building

• Healthcare
• Science & Research

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine