eTMF/CTMS Systems Lead for Regulatory Trials

Milestone Pharmaceuticals, Inc.; Charlotte (NC); On-site; USD 95,000 - 135,000; Full time

Job summary

Milestone Pharmaceuticals, Inc. is seeking an experienced TMF/CTMS Manager to oversee clinical trial management systems and electronic TMF files. You will ensure data accuracy, appropriate access, and readiness for inspections while supporting cross-functional teams across clinical operations, IT, and QA.

The role requires a bachelor’s degree and a minimum of 2+ years working with FLEX Databases, CTMS, and eTMF modules, with a strong focus on GCP compliance and process improvement.

Qualifications

• Minimum of 2 years’ experience with FLEX Databases systems, including CTMS and eTMF management.
• Experience managing CTMS and eTMF configurations and validation.
• Strong understanding of GCP/ICH regulations and regulatory compliance.

Responsibilities

• System Administration: overseeing CTMS/eTMF configuration, validation, and user access; maintain TMF/CTMS documentation.
• Quality Control & Compliance: perform risk-based reviews, ensure SOPs/ICH‑GCP alignment, support inspections and audits.
• Cross-Functional Collaboration: partner with clinical ops, IT, and QA to resolve system issues and drive adoption.
• Vendor & Project Management: coordinate with CROs and external vendors; track milestones and generate status reports.
• Training & Process Improvement: develop SOPs, training materials, and dashboards for leadership reporting.

Skills

CTMS management

eTMF management

FLEX Databases

Regulatory compliance

GCP knowledge

Documentation & SOPs

Education

Bachelor’s degree or equivalent

Tools

FLEX Databases

CTMS

eTMF

Job description

Milestone Pharmaceuticals, Inc. is seeking an experienced TMF/CTMS Manager to oversee clinical trial management systems and electronic TMF files. You will ensure data accuracy, appropriate access, and readiness for inspections while supporting cross-functional teams across clinical operations, IT, and QA.

The role requires a bachelor’s degree and a minimum of 2+ years working with FLEX Databases, CTMS, and eTMF modules, with a strong focus on GCP compliance and process improvement.