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Clinical Study Development Specialist

hace 2 semanas

Buenos Aires, Buenos Aires C.F., Argentina Innovaderm Research A tiempo completo

Job Overview

We are looking for a talented Clinical Study Builder to join our team at Innovaderm Research. As a key member of our team, you will be responsible for designing and developing electronic case report forms (eCRFs), visit schedules, and associated data quality checks for medical research studies.

This role requires strong collaboration and communication skills, as you will work closely with data management and statistical staff to create innovative solutions. You will be responsible for implementing, testing, and system integrations, primarily using Veeva CDMS but also Medrio or Rave as required.

Main Responsibilities

  1. Design and develop eCRFs, visit schedules, and associated data quality checks for medical research studies.
  2. Collaborate with data management and statistical staff to create innovative solutions.
  3. Implement, test, and integrate systems, primarily using Veeva CDMS but also Medrio or Rave as required.
  4. Set up Coder, Local Lab, Targeted SDV modules.
  5. Lead eCRF design and review meetings.
  6. Provide user support and technical support.
  7. Conduct end-user training.
  8. Work collaboratively with Lead Data Managers.
  9. Work effectively with vendor partners in testing and deployment.
  10. Troubleshoot and resolve technical issues in a timely manner.
  11. Participate in the definition, writing, and updating of Veeva CDMS SOPs.

About Innovaderm Research

Innovaderm Research is a global clinical leader in dermatology, with over two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes. We offer a stimulating work environment and attractive advancement opportunities.

Your Background

  • Bachelor's or Master's degree in a related field of study.
  • Minimum 2 years of Veeva CDMS study build experience.
  • Certified Veeva Study Builders preferred.
  • Medidata Rave build experience preferred.
  • Detailed knowledge and experience in case report form design, programming databases.
  • Must be able to lead multiple study builds or post-release changes at the same time.
  • Understanding of the drug development process and applicable regulations, including Good Clinical Practices, ICH Guidelines.
  • Highly organized and detail-oriented with effective project planning and time management skills.
  • Strong verbal and written communication skills in English.
  • Ability to work in a fast-paced environment with demonstrated agility to juggle and prioritize multiple competing demands.