Clinical Systems Architect — eTMF & CTMS Expert

BD Mexico; Sparks Corner (MD); On-site; USD 90,000 - 120,000; Full time

Job summary

BD is seeking a Clinical Systems Specialist to optimize eTMF and CTMS within a regulated environment. You will configure, administer, and train users while collaborating with Clinical Operations, Data Management, Medical Affairs, Quality, Regulatory Affairs, and IT to ensure inspection readiness.

In this role, you will drive system adoption, maintain TMF health, create dashboards and metrics, and support validations, data loads, and integrations.

Qualifications

• Bachelor's degree and minimum 2 years in Clinical Operations or related fields.
• Experience supporting, administering, or configuring eTMF and CTMS in regulated environments.
• Ability to develop user documentation and training materials.

Responsibilities

• Administer and support eTMF and CTMS, including user provisioning and access reviews.
• Configure workflows, reports, dashboards, and metadata for clinical operations.
• Support testing, validation documentation, and defect tracking.
• Execute data loads, bulk updates, and data remediation tasks.
• Generate reports and KPIs to support study teams and management.
• Promote best practices and drive system adoption across teams.

Skills

Clinical systems experience

eTMF/CTMS administration

Regulatory/compliance knowledge

Veeva Vault familiarity

Documentation/training materials

Education

Bachelor's degree in Life Sciences, Clinical Research, Information Systems, Healthcare Administration, or related field

Tools

Veeva Vault eTMF

Veeva CTMS

Power BI / Power Query

Excel

Job description

BD is seeking a Clinical Systems Specialist to optimize eTMF and CTMS within a regulated environment. You will configure, administer, and train users while collaborating with Clinical Operations, Data Management, Medical Affairs, Quality, Regulatory Affairs, and IT to ensure inspection readiness.

In this role, you will drive system adoption, maintain TMF health, create dashboards and metrics, and support validations, data loads, and integrations.