Hybrid Study Startup Specialist I - France

Psi CRO; Saint-Maur-des-Fossés; Hybrid; EUR 45,000 - 65,000; Full time

Job summary

Psi CRO is seeking a Study Startup Specialist to support onboarding in France. The role requires coordinating site identification, document review for ethics/regulatory approvals, and preparation of site contracts and budgets.

You will work with project teams, sites, vendors, and regulatory bodies to ensure timely site activation. The position is hybrid in Saint-Maur-des-Fossés and demands strong English and French communication, organizational skills, and the ability to negotiate with diverse

Qualifications

• College/University degree or an equivalent combination of education, training and experience.
• At least 1 year industry experience in clinical research and/or a minimum 1 year of Study Startup experience in Italy.
• Full working proficiency in English and French.
• Communication and organizational skills.
• Ability to negotiate and build relationships at all levels.
• Your CV must be submitted in English.

Responsibilities

• Support site identification and selection process
• Collect and review documents for ethics and regulatory review and approval
• Prepare packages of site documents for drug release to clinical sites
• Prepare and negotiate site contracts and budgets
• Communicate with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters till the moment of site activation
• Maintain trial-specific tracking systems and the electronic Trial Master File (eTMF) throughout the study start-up phase
• Monitor startup metrics and timelines
• Coordinate initiatives for startup process improvement, analyse best practices and challenges

Skills

Communication

Organizational skills

Negotiation

Education

University degree

Job description

Psi CRO is seeking a Study Startup Specialist to support onboarding in France. The role requires coordinating site identification, document review for ethics/regulatory approvals, and preparation of site contracts and budgets.

You will work with project teams, sites, vendors, and regulatory bodies to ensure timely site activation. The position is hybrid in Saint-Maur-des-Fossés and demands strong English and French communication, organizational skills, and the ability to negotiate with diverse