Clinical Study Manager

Mobia Medical•Fridley, MN

5d•$110,000 - $160,000

About The Position

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.

Requirements

Bachelor’s degree in life sciences, nursing, engineering, or related scientific discipline required
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

Nice To Haves

Advanced degree preferred
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
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 risks
Detail-oriented with a strong commitment to data quality and regulatory compliance
An effective communicator who builds trusted relationships with study sites and internal stakeholders

Responsibilities

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