Study Startup Lead

at  PSI CRO

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 Argentina. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time.
Hybrid work in Buenos Aires.
Only CV’s in English will be considered.

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 Argentina/Latin America
• 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
  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

Please refer the Job description for details