Study Startup Specialist

Posted 4 Hours Ago
Be an Early Applicant
Buenos Aires, Ciudad Autónoma de Buenos Aires
Entry level
Pharmaceutical
The Role
The Study Startup Specialist will support the operational processes for site activation in clinical trials, ensuring timely and smooth project startup. Responsibilities include supporting feasibility studies, maintaining project tracking systems, handling site agreements, and facilitating communication among all parties involved in the clinical projects.
Summary Generated by Built In

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 2,600 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 Latam. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time. 

Hybrid position in Buenos Aires
Only CVs in English will be considered

You will:

  • Support all processes for site activation
  • Support Feasibility department with research and site identification process
  • Maintain project-specific tracking systems and electronic Trial Master File (eTMF) throughout study startup phase 
  • Provide administrative support with site agreement and budgets
  • Assist with site documents collection for IRB/IEC submission and/or IP-RED process
  • Provide progress updates to all parties
  • Identify project-specific issues and escalate as outlined in the project specific Communication Plan 
  • Support preparation of study dossiers to sites and competent authorities 
  • Support preparation of IP-RED packages
  • Ensure exchange of information and documentation with investigational sites, off -site facilities and vendors throughout study startup phase

Qualifications

  • College/University degree or an equivalent combination of education, training and experience
  • Prior study and site startup experience in Latin America
  • Full working proficiency in English and Spanish
  • Communication and organizational skills
  • Ability to negotiate and build relationships at all levels

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.

The Company
HQ: Zug
1,939 Employees
On-site Workplace
Year Founded: 1995

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

Similar Jobs

ZS Logo ZS

Business Technology Solutions Associate Consultant - Salesforce Experience

Artificial Intelligence • Healthtech • Professional Services • Analytics • Consulting
Hybrid
Ciudad Autónoma de Buenos Aires, ARG
13000 Employees

ZS Logo ZS

Senior Project Manager - PMO

Artificial Intelligence • Healthtech • Professional Services • Analytics • Consulting
Hybrid
Ciudad Autónoma de Buenos Aires, ARG
13000 Employees

ZS Logo ZS

Lead Software Engineer - Back End

Artificial Intelligence • Healthtech • Professional Services • Analytics • Consulting
Hybrid
Ciudad Autónoma de Buenos Aires, ARG
13000 Employees

Pfizer Logo Pfizer

Tech Transfer & NIP Manager

Artificial Intelligence • Healthtech • Machine Learning • Natural Language Processing • Biotech • Pharmaceutical
Hybrid
Buenos Aires, Ciudad Autónoma de Buenos Aires, ARG
121990 Employees

Similar Companies Hiring

Novo Nordisk Thumbnail
Software • Pharmaceutical • Healthtech
Bagsværd, DK
69000 Employees
Zealthy Thumbnail
Telehealth • Social Impact • Pharmaceutical • Healthtech
New York City, NY
13 Employees
Cencora Thumbnail
Pharmaceutical • Logistics • Healthtech
Conshohocken, PA
46000 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account