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
Skills Required
- Minimum of 2 years of experience with FLEX Databases systems, including CTMS and eTMF management
- Primary experience managing implementation and configuration of eTMF and CTMS modules within FLEX Databases
- Experience leading or contributing to validation of CTMS and eTMF modules within FLEX Databases
- Bachelor's degree or equivalent
- Experience with a pharmaceutical sponsor or CRO
- Thorough understanding of GCP, ICH regulations, and regulatory compliance
- Strong attention to detail and organizational skills
- Ability to identify and resolve issues and manage timelines effectively
What We Do
Thank you for your interest in Milestone Pharmaceuticals. While we encourage you to explore opportunities with our company, we urge you to be cautious and wary of recruitment scams in which fraudsters pose as representatives of Milestone Pharma. All current openings are available to view on our Careers page. https://milestonepharmaceuticals.applytojob.com/ Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a Phase 3 clinical-stage biopharmaceutical company dedicated to developing and commercializing the investigational new drug etripamil for the treatment of cardiovascular indications. Etripamil is a novel, potent and short-acting calcium channel blocker designed by Milestone and being developed as a rapid-onset nasal spray to be administered by the patient to terminate episodes of PSVT as they occur. Milestone is actively recruiting patients for a Phase 3 clinical trial of etripamil for the treatment of PSVT. Milestone plans to initiate a Phase 2 clinical trial in atrial fibrillation, another rapid heart rate condition, and expects to subsequently initiate an additional Phase 2 clinical trial in angina to establish proof-of-concept for the broader use of etripamil.
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