Study Startup Lead

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 2,700 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 Mexico. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time. 

Home-based

You will:

• Oversee and coordinate the processes critical for clinical trial sites activation
• Communicate with project teams, investigative sites, review bodies, vendors, and clients regarding startup matters till the moment of site activation
• Support site identification and selection process
• Collect, review, and submit documents for ethics and regulatory review and approval
• Prepare packages of site documents for drug release to clinical sites
• Develop and negotiate site contracts and budgets
• Monitor startup metrics and timelines
• Coordinate initiatives for startup process improvement, analyze best practices and challenges

Qualifications

• College/University degree or an equivalent combination of education, training and experience
• Minimum 3 years of industry experience in clinical research with practical startup experience in the Country/ Region
• Excellent knowledge of ICH GCP, local laws and applicable regulations in the region
• Full working proficiency in English and Spanish
• Communication and organizational skills
• Ability to negotiate and build relationships at all levels
• Experience in mentoring and leadership is preferred

Additional Information

What we offer:

• We value your time so the recruitment process is as quick as 3 on-line meetings
• We'll prepare you to do your job at highest quality level with our extensive onboarding and mentorship program
• You'll have permanent work agreement at a stable, privately owned company
• We care about our employees - aside from competitive salary, you'll have good work-life balance and attractive benefits
• We're constantly growing which means opportunities for personal and professional growth 

Please note: only CVs in English will be considered