Job 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.

Essential Functions

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

Principal Clinical Database Manager

Descripción del empleo

Sobre la empresa

Importante