Clinical Study Manager
Listed on 2026-07-30
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Research/Development
Regulatory Compliance Specialist, Clinical Research
About this position
About Mobia Medical
Mobia Medical is a commercial-stage medtech company delivering breakthrough stroke recovery solutions. The company’s Vivistim® Paired VNS™ Therapy is the first and only FDA‑approved implantable solution designed to improve function in chronic ischemic stroke survivors with moderate to severe upper limb impairments. Vivistim® Paired VNS™ Therapy combines targeted vagus nerve stimulation with functional movement to promote neuroplasticity and improve the brain’s ability to relearn motor skills.
Mobia Medical is mobilizing patients, providers, and care partners to establish a better way forward in stroke care.
About the role
The Clinical Study Manager is a key member of the Clinical Affairs team, responsible for leading the operational execution and management of clinical studies that support the company’s clinical development programs.
In this role, you will partner closely with Clinical, Regulatory, Data Management, Biostatistics, and cross‑functional teams to ensure clinical studies are executed efficiently, compliantly, and with high‑quality data outcomes. You will play a critical role in supporting feasibility, pivotal, and post‑market studies while driving operational excellence and maintaining strong relationships with investigational sites and external partners.
What you'll do
Lead clinical study execution and operations
- Manage clinical studies from start‑up through close‑out, ensuring timelines, deliverables, and study objectives are achieved
- Develop and manage study timelines, enrollment plans, tracking tools, and operational deliverables
- Support implementation of monitoring plans, enrollment initiatives, and risk mitigation strategies
- Identify and proactively resolve operational, enrollment, compliance, and data quality challenges
Drive site management and investigator engagement
- Support site qualification, initiation, interim monitoring, and close‑out activities
- Build and maintain strong relationships with investigators, research coordinators, and study personnel
- Coordinate investigator meetings and site training activities
- Ensure investigators and site staff are trained on protocols, investigational devices, EDC systems, and regulatory requirements
- Support enrollment and retention initiatives while ensuring protocol adherence and informed consent compliance
Ensure data quality and regulatory compliance
- Ensure accurate, complete, and timely collection of clinical trial data
- Monitor study metrics and trends to identify risks or quality concerns
- Identify protocol deviations, safety concerns, and noncompliance issues and ensure appropriate escalation and resolution
- Support audit and inspection readiness activities
- Assist with preparation of study reports, annual reports, and clinical documentation submissions
Collaborate cross‑functionally and support continuous improvement
- Partner with Data Management, Biostatistics, Regulatory, and Clinical teams to support study execution and reporting
- Manage and oversee CROs, vendors, and external study partners to ensure high‑quality deliverables
- Contribute to process improvement initiatives within Clinical Operations
Qualifications
What you bring:
- Bachelor’s degree in life sciences, nursing, engineering, or related scientific discipline required
- Advanced degree preferred
- 5+ years of clinical research experience in medical device, biotechnology, or pharmaceutical industries
- 3+ years of clinical study management or clinical operations experience
- Experience supporting feasibility, pivotal, and/or post‑market clinical studies
- Strong understanding of clinical trial operations, site management, and study execution
Preferred qualifications:
- Experience supporting multicenter clinical trials
- Experience managing CROs and external vendors
- Strong knowledge of FDA regulations, GCP, and clinical research compliance requirements
- Experience with EDC systems, CTMS platforms, and clinical trial tracking tools
You’ll thrive in this role if you are:
- Highly organized with strong project management and prioritization skills
- A collaborative team player who works effectively across cross‑functional groups
- A proactive problem solver who can identify and mitigate study…
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