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Clinical Study Designer
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Clinical Study Designer
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Clinical Study Designer
1 month ago
We are seeking a highly skilled Clinical Study Builder to join our team at Innovaderm Research. As a key member of our data management 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.
Key Responsibilities- Develop programming/configuration of Veeva and Medrio CRFs, folders, edit checks, derivations, integrations, migrations, and reports, based on protocol requirements.
- Set up Coder, Local Lab, Targeted SDV modules.
- Lead eCRF design and review meetings.
- Provide user support and technical support.
- Conduct end-user training.
- Work collaboratively with Lead Data Managers.
- Work effectively with vendor partners in testing and deployment.
- Troubleshoot and resolve technical issues in a timely manner.
- Participate in the definition, writing, and updating of Veeva CDMS SOPs.
- Bachelor's or Master's degree in a related field of study.
- Minimum of 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.
- Ability to lead multiple study builds or post-release changes at the same time.
- Understanding of the drug development process and of 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.
Innovaderm Research is a contract research organization (CRO) specialized in dermatology. We are committed to providing equitable treatment and equal opportunity to all individuals. We offer a stimulating work environment and attractive advancement opportunities.
This is a home-based position in India, and attendance at some meetings outside of regular business hours (primarily in the evening) is required.
