Customer Service and Business Administration Specialist

Descripción del trabajo

Planet Pharma is partnered with a global, full-service Contract Research Organization (CRO), who are currently hiring for a Clinical Study Builder on a fully remote basis.

Main Responsibilities :

• Collaborate with data management and statistical teams to design and develop electronic case report forms (eCRFs), visit schedules, and data quality checks.
• Implement, test, and integrate systems to support medical research studies.
• Primarily build CRFs using Veeva CDMS, with possible work on Medrio or Rave EDC systems.
• Ensure compliance with regulatory requirements, industry guidelines, and Innovaderm's standard operating procedures (SOPs).
• Adhere to sponsor requirements and project timelines while maintaining high-quality standards.
• Set up Coder, Local Lab, and Targeted SDV modules for clinical studies.
• Lead eCRF design and review meetings to ensure study requirements are met.
• Provide user and technical support, including troubleshooting and timely issue resolution.
• Conduct end-user training on system functionalities and processes.
• Collaborate closely with Lead Data Managers to optimize data collection and management.
• Work with vendor partners to support testing and deployment of clinical study systems.
• Assist in defining, writing, and updating Veeva CDMS SOPs to maintain compliance and efficiency.

Main Requirements :

• B.Sc. or M.Sc. in a related field.
• Minimum 2 years of experience in Veeva CDMS study build.
• Experience with Medidata Rave build is a plus.
• Strong expertise in case report form (CRF) design and database programming.
• Ability to manage multiple study builds and post-release changes simultaneously.
• Understanding of the drug development process and regulatory guidelines (Good Clinical Practices, ICH).

Interested? Apply now for immediate consideration or contact Maria Tsalpatourou at Planet Pharma.

Planet Pharma is an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion / belief, sexual orientation or age.