Clinical Study Builder-Romania

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 is required to work in a dynamic and collaborative environment. In addition, solution creation includes implementation , testing, and system integrations. The Clinical Study Builder will work principally on Veeva CDMS, but might also be requested to build CRF using different EDC systems, like Medrio or Rave.

In addition, this position is required to conduct all these activities in conformance with applicable regulatory requirements, industry guidelines, and Indero standard operating procedures (SOPs) while respecting Indero’s commitment to sponsor’s requirements and timelines

More specifically, the Clinical Study Builder must:

• 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

Education

• B.Sc. or M.Sc, or in a related field of study;



Experience

• Minimum of 2 years of Veeva CDMS study build experience;

Knowledge and skills

• 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.

The work environment 

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

In this position, you will be eligible for the following perks: 

• Flexible work schedule / work schedule :
• Home-based position
• Ongoing learning and development 

About Indero  

A Global Clinical Leader In Dermatology!

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. 

Indero only accepts applicants who can legally work in Romania