Clinical Study Designer

4 weeks ago


Pune, Maharashtra, India Innovaderm Research Full time

Clinical Study Builder Job Description

The Clinical Study Builder will work closely with data management and statistical staff to design and develop electronic case report forms (eCRFs), visit schedules, and associated data quality checks for medical research studies. This position requires working in a dynamic and collaborative environment. Solution creation involves implementation, testing, and system integrations. The Clinical Study Builder will work primarily on Veeva CDMS but may also be requested to build CRFs using different EDC systems, like Medrio or Rave.

This position requires conducting all activities in conformance with applicable regulatory requirements, industry guidelines, and Innovaderm standard operating procedures (SOPs) while respecting Innovaderm's commitment to sponsors' requirements and timelines.

Key Responsibilities:

  • Develops programming/configuration of Veeva and Medrio CRFs, folders, edit checks, derivations, integrations, migrations, and reports based on protocol requirements.
  • Sets up Coder, Local Lab, Targeted SDV modules.
  • Leads eCRF design and review meetings.
  • Provides user support and technical support.
  • Conducts end-user training.
  • Works collaboratively with Lead Data Managers.
  • Works effectively with vendor partners in testing and deployment.
  • Troubleshoots and resolves technical issues in a timely manner.
  • Participates in the definition, writing, and updating of Veeva CDMS SOPs.

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Innovaderm continues to grow and expand in North America and Europe.

Requirements:

  • B.Sc. or M.Sc. or 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;
  • Must be able 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.


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