Principal Clinical Database Manager

IQVIA; Santiago; Presencial; CLP 44.444.444 - 62.222.222; Jornada completa

Descripción de la vacante

IQVIA in Santiago, Chile, is seeking a skilled individual to oversee study build and design for clinical research projects. You will collaborate with stakeholders, manage project timelines, and ensure compliance with industry standards.

The ideal candidate will possess a Bachelor's Degree in Science or Technology, with 4-6 years of relevant experience, especially in Medidata RAVE. This role is essential for successful project delivery and process improvement within the organization.

Formación

• 4 to 6 years of relevant core technical designer experience.
• 9 years of overall experience in clinical research data management.
• Hands-on experience designing in Medidata RAVE.

Responsabilidades

• Responsible for study build & design, ensuring project timelines.
• Updates eCRF using CDMS tools according to industry standards.
• Ensure completion of project-specific training and documentation.

Conocimientos

Clinical research data management

Data design in Medidata RAVE

Project risk management

Educación

Bachelor's Degree in Science/Computer science/Information Technology

Descripción del empleo

Overview

Responsible for study build & design, edit specifications, system configurations and is accountable for associated study design components. This role will collaborate with various stakeholders- DTL, Programmer, Validation Team, vendors, statisticians, and client representatives. In addition to project deliveries, the role also would be responsible for the project financials from programming shared services perspective.

Responsibilities

• Interprets the study protocol.
• Design and update the eCRF using third party or in house CDMS tools in alignment with industry standards like SDTM, CDASH as applicable.
• Create and update Edit Specification Document.
• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page).
• Complete the Study Authorization Form and Trial Capacity Request Form (InForm).
• Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting.
• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.
• Design the database to collect LLRR data within the InForm database and ensure Rights and Roles document has appropriate access for Entry and Updates.
• Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.
• Escalate potential quality issues.
• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.
• Reviews build timelines and provide input as applicable.
• Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties.
• Responsible for multiple study design projects at the same time.
• Might be working on projects across multiple platforms.
• Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.
• All responsibilities are essential job functions unless noted as nonessential (N).

Qualifications

• Bachelor's Degree in Science/Computer science/Information or Technology is mandatory.
• 4 to 6 years of relevant core technical designer experience.
• 9 years of overall experience in clinical research data management.
• Hands-on experience designing in Medidata RAVE.
• Based in Latinamerica, home base role.