The manager oversees the configuration, validation, and day-to-day operations of CTMS and eTMF platforms within FLEX Databases. They are responsible for ensuring regulatory compliance, managing vendor relationships, and supporting cross-functional teams to maintain inspection readiness.
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
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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