Study Startup Specialist I

PSI CRO; Saint-Maur-des-Fossés; Híbrido; EUR 45.000 - 65.000; Jornada completa

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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

Conocimientos

Communication

Organizational skills

Negotiation

Educación

University degree

Descripción del empleo

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.

Job Description

Take your career to the next level and be involved in study startup processes in France. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.

This role is hybrid in our Saint-Maur-des-Fossés office

You will:

• 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

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 inItaly
• 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

Additional Information

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.