Clinical Study Builder
New
CanadaFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- English
- Experience
- Minimum of 2 years of experience in Veeva CDMS study builds
- Required Skills
- GCP
Requirements
- Bachelor’s or Master’s degree in a relevant field.
- Minimum of 2 years of experience in Veeva CDMS study builds; experience with Medidata Rave preferred.
- Certification as a Veeva Study Builder is advantageous.
- Strong knowledge of case report form design, database programming, and study build processes.
- Understanding of drug development processes, Good Clinical Practices (GCP), and ICH guidelines.
- Highly organized, detail-oriented, and capable of managing multiple priorities in a fast-paced environment.
- Excellent verbal and written communication skills in English, with the ability to support cross-functional teams.
Responsibilities
- Develop, configure, and maintain eCRFs, visit schedules, edit checks, derivations, integrations, migrations, and reports using systems such as Veeva CDMS, Medrio, and Rave.
- Lead design and review meetings for study protocols, ensuring alignment with regulatory and project requirements.
- Provide technical and user support to internal and external stakeholders, troubleshooting and resolving issues efficiently.
- Conduct end-user training and maintain documentation, including updates to Standard Operating Procedures (SOPs).
- Collaborate closely with Lead Data Managers and vendor partners throughout testing, deployment, and post-release changes.
- Manage multiple study builds or updates simultaneously, maintaining accuracy and adherence to timelines.
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