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:
- Lead all study startup activities/processes with local project teams
- Support activities in feasibility research and site identification process
- Oversee electronic Trial Master File (eTMF) maintenance during startup phase
- Coordinate activities on negotiation of site agreement and/or budget to ensure alignment to the site activation plan
- Identify project-specific issues and escalate to all functions concerned as outlined in the Project Communication Plan
- Supervise preparation and/or submission of the study dossiers to sites, to the competent authorities, IRBs/IECs, etc.
- Review IP-Reds packages
- Oversee and report on the site activation progress of the clinical sites
- 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.
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas.
PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines.
PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world.
PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees.
http://www.psi-cro.com
