Overview
Schedule
Full-time
Career level
Director
Remote
On-site
Benefits
Career Development
Job Description
WHY JOIN MILESTONEAt 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 andempowerments are continually upheld as central to our mission. Our teamwork is strengthened in an environmentin which we support and challenge each other while enjoying and celebrating our achievements. We maintain anentrepreneurial, 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 bothsupported and sought. We act individually and as a team with humility, candor, empathy, and unwaveringintegrity.We have been successful in attracting and empowering best‐in‐class talent, and we seek those with passion to joinon our journey to develop treatments and to motivate change. We are excited about possibilities of this team andwhat 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.
- 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
EEOC STATEMENT: Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
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FAQs About Manager eTMF and Clinical Trial Management System (CTMS) Jobs at Milestone Pharmaceuticals
What is the work location for this position at Milestone Pharmaceuticals?
This job at Milestone Pharmaceuticals is located in Charlotte, NC, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Milestone Pharmaceuticals?
Employer has not shared pay details for this role.
What employment applies to this position at Milestone Pharmaceuticals?
Milestone Pharmaceuticals lists this role as a Full-time position.
What experience level is required for this role at Milestone Pharmaceuticals?
Milestone Pharmaceuticals is looking for a candidate with "Director" experience level.
What benefits are offered by Milestone Pharmaceuticals for this role?
Milestone Pharmaceuticals offers Career Development for this position. Actual benefits may vary depending on the employer's policies and employment terms.
What is the process to apply for this position at Milestone Pharmaceuticals?
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