Study Startup Specialist I

Psi CRO; Monza; Hybrid; EUR 32,000 - 40,000; Full time

Benefits offered by this job

Bonus

Incentive plans

Other benefits may apply

Job summary

Psi CRO is seeking a Study Start-Up coordinator in the Milan area to drive activation of clinical sites in Italy. You will partner with project teams, sites, vendors, and review bodies to streamline ethics, regulatory submissions, and site activation while monitoring timelines and pushing process improvements.

The role requires a university degree, at least 1 year in clinical research or study startup in Italy, and full English proficiency.

Qualifications

• College/University degree or equivalent education/experience.
• At least 1 year of industry experience in clinical research and/or at least 1 year of Study Startup experience in Italy.
• Full working proficiency in English.
• Strong communication and organizational skills.
• Ability to negotiate and build relationships at all levels.

Responsibilities

• Coordinate startup activities to activate clinical sites in Italy.
• Review ethics and regulatory submissions and prepare site packages.
• Prepare and negotiate site contracts and budgets.
• Communicate with project teams, sites, vendors, review bodies, and clients about startup matters.
• Monitor startup timelines and contribute to process improvements.

Skills

Communication

Organizational skills

Negotiation

English proficiency

Education

College/University degree or equivalent

Job description

In this role you will drive study startup activities to ensure timely activation of clinical sites in Italy. You will partner with project teams, sites, vendors, and review bodies to streamline ethics, regulatory submissions, and site activation. You’ll monitor startup timelines, optimize processes, and contribute to a global pharmacovigilance-minded mission. This position blends hands-on coordination with process improvement in a hybrid Milan setting, offering growth within a patient-focused pharmaceutical environment.

• base salary 31,700 – 40,150 gross annual salary
• bonus
• incentive plans
• other benefits may apply
• Support site identification and selection process
• Collect and review documents for ethics and regulatory review and approval
• Prepare site document packages 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 until site activation
• Monitor startup metrics and timelines
• Coordinate initiatives for startup process improvement, analyze best practices and challenges
• College/University degree or equivalent education/experience
• At least 1 year of industry experience in clinical research and/or at least 1 year of Study Startup experience in Italy
• Full working proficiency in English
• Strong communication and organizational skills
• Ability to negotiate and build relationships at all levels
• communication
• organizational skills
• ethics and regulatory submission
• site activation processes
• contract and budget negotiation