Principal Clinical Database Designer, Bellville

Overview Lead and oversee a team of clinical database design professionals responsible for the delivery and build of multiple clinical studies across various platforms. Serve as a client-facing representative for the clinical database design function, with accountability for project financials, scope management, and relationship development. Act as a Subject Matter Expert (SME) supporting IT teams on software application maintenance and adoption as needed.

Essential Functions

Serve in a global SME role for clinical database design and data management.

May act as a global librarian, supporting and performing CAPA activities, issue management, and escalations.

Perform project financial checks and reviews, including budget monitoring and variance analysis.

Define, prioritize, and manage resource requirements and assignments across projects.

Implement departmental and office objectives; conduct peer reviews at a portfolio level.

Provide expert review and guidance on Data Management deliverables, including:

CRF/eCRF design

Database design and setup

Validation definition and programming

Data Management Plans

Database deliverables for internal and external customers

Offer technical guidance and solutions to internal and external stakeholders to resolve issues and improve efficiency.

Participate in the development and implementation of new processes and technologies.

Ensure staff are trained and compliant with current SOPs, work instructions, and project scope. Identify and address professional development and training needs.

Mentor team members to strengthen Data Management programming processes, systems, and drug development expertise.

Provide design and programming input into proposals and scopes of work; may participate in proposal defenses.

Lead or attend customer meetings to discuss project programming requirements and strategic planning.

Maintain a thorough understanding of scope of work, budgets, and assumptions. Identify out-of-scope activities and prepare revised cost estimates with supporting documentation.

Ensure project milestones are met according to agreed timelines and actively manage quality throughout the project lifecycle.

Perform people management responsibilities, including planning, assigning, and directing work.

Qualifications

Bachelor’s degree in Science, Computer Science, Information Technology, or Technology (required).

4–6 years of relevant core technical designer experience, with 9+ years of total professional experience (required).

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