eTMF and Clinical Trial Management System (CTMS)

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

WHY JOIN MILESTONE

At Milestone, we aspire to advance and implement paradigm shifts for cardiac therapy. We are currently focused on developing anti‑arrhythmia treatments for self‑administration outside of the emergency department or hospital setting for patients with acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib), as well as other episodic cardiovascular conditions.

In addition to our science and innovation, we are a team guided and driven by our core values. Patient needs and empowerments are continually upheld as central to our mission. Our teamwork is strengthened in an environment in which we support and challenge each other while enjoying and celebrating our achievements. We maintain an entrepreneurial, proactive, and action‑oriented mindset that places high value on grit, courage, and resolve. Decision‑making is based on evaluating information and an idea’s merits; data‑driven proposals are both supported and sought. We act individually and as a team with humility, candor, empathy, and unwavering integrity.

We have been successful in attracting and empowering best‑in‑class talent, and we seek those with passion to join on our journey to develop treatments and to motivate change. We are excited about possibilities of this team and what we can accomplish together.

The eTMF and CTMS Manager oversees clinical trial management systems and electronic trial master files to ensure data accuracy, user access, and inspection readiness. The role requires a bachelor's degree, 6+ years in clinical research, expertise in platforms (FLEX Databases preferred) and strong knowledge of global regulatory compliance.

KEY RESPONSBILITIES:

• System Administration: Oversee the configuration and validation of CTMS and eTMF platforms within FLEX Databases system. Manage day-to-day operations, configuration updates, user provisioning, and user access for CTMS and eTMF platforms. Prepare and maintain documentation related to TMF/CTMS processes, procedures, and metrics.


• Quality Control & Compliance: Perform risk-based quality reviews of trial documents, ensure compliance with SOPs and ICH‑GCP guidelines, and maintain continuous inspection readiness. Support regulatory inspections and audits by providing requested documents and information, as required.


• Cross-Functional Collaboration: Partner with clinical operations, IT, and quality assurance (QA) teams to resolve system issues and support user adoption.


• Vendor & Project Management: Coordinate with external vendors and Contract Research Organizations (CROs) to track milestones, metrics, and document reconciliation. Generate TMF/CTMS status reports for management review and project team meetings.


• Training & Process Improvement: Act as a subject matter expert on TMF/CTMS management. Develop training materials, standard operating procedures (SOPs), and dashboards to report study metrics to leadership.

ABOUT YOU:

• Minimum of 2 years’ experience with FLEX Databases systems, including CTMS and eTMF management


• Have been the primary person managing the implementation and configuration of eTMF and CTMS modules within FLEX Databases system


• Lead or key contributor to the validation of CTMS and eTMF modules within FLEX Databases system


• Bachelor’s degree or equivalent


• Preferred experience with a pharma sponsor or CRO


• Must have thorough understanding of GCP and ICH regulations, and regulatory compliance


• Highly detail oriented personality with very strong organizational skills


• Demonstrated ability to identify and resolve issues and effectively manage timelines