Clinical Research Manager

Company

Longeviti is a medical technology company advancing neurosurgical care through the ClearFit® platform, a Brain Ultrasound Interface (BUI) platform that enables ultrasound imaging through sonolucent cranial implants. Longeviti works with neurosurgeons, academic medical centers, and clinical research collaborators to generate evidence supporting safer, more efficient postoperative monitoring for patients with neurological disease.

Location

Baltimore, Maryland preferred. In-person or in-office presence is strongly preferred. Hybrid arrangements may be considered for exceptional candidates, with travel to participating clinical sites as needed.

Position Summary

Longeviti is seeking a Clinical Research Manager to serve as the company’s internal clinical operations lead for Longeviti-sponsored clinical research studies. This person will function as a sponsor-side “one-person CRO,” owning the day-to-day execution of clinical research operations, including site startup, IRB coordination, study documentation, site management, monitoring, data quality, project tracking, adverse event reporting, and study closeout.

This is a hands-on role for someone who can independently manage clinical research operations in a lean, entrepreneurial environment while maintaining the rigor expected in multi-center clinical research. The Clinical Research Manager will coordinate with clinical sites, investigators, research coordinators, IRBs, vendors, and internal Longeviti stakeholders to ensure studies are executed efficiently, compliantly, and with strong documentation discipline.

Key Responsibilities

Clinical Study Operations

• Serve as Longeviti’s primary internal owner for sponsored clinical research operations.
• Lead operational execution of Longeviti-sponsored studies from startup through closeout.
• Build and manage study timelines, site activation plans, monitoring plans, communication cadences, action-item trackers, and follow-up dashboards.
• Coordinate study startup, enrollment support, protocol implementation, data collection, monitoring, and closeout activities.
• Ensure study activities are conducted in accordance with the protocol, applicable regulations, IRB requirements, Good Clinical Practice principles, and Longeviti internal expectations.
• Provide regular study status updates to Longeviti leadership, investigators, advisors, and external collaborators.

Site Management and Study Execution

• Serve as the primary sponsor-side contact for participating clinical sites.
• Manage site onboarding, training, activation, enrollment tracking, data collection, follow-up completion, and study closeout.
• Coordinate with principal investigators, neurosurgeons, radiologists, clinical research coordinators, research offices, and site administrators.
• Track study milestones, patient follow-up schedules, missed visits, non-evaluable data, protocol deviations, and site-level performance.
• Support compliance with study-specific workflows, including documentation, data entry, imaging-related procedures where applicable, and required study timelines.
• Identify operational risks early and drive timely resolution.

IRB, Regulatory, and Documentation

• Coordinate IRB submissions, amendments, continuing review, reportable events, reliance documentation, and closeout submissions.
• Manage central IRB and local site documentation requirements as applicable.
• Coordinate site regulatory documentation, including investigator documents, delegation logs, training documentation, consent materials, approvals, and protocol versions.
• Maintain an organized, audit-ready trial master file or sponsor study file.
• Ensure appropriate documentation of protocol deviations, adverse events, serious adverse events, and study-related issues.
• Prepare study documentation for internal review, IRB reporting, sponsor oversight, and potential audits.

Monitoring and Compliance

• Develop and execute a pragmatic monitoring plan appropriate for Longeviti-sponsored studies.
• Conduct or coordinate remote and/or on-site monitoring activities.
• Review source documentation, informed consent documentation, case report forms, data queries, regulatory files, and protocol compliance.
• Track and resolve monitoring findings, documentation gaps, data discrepancies, and site-level issues.
• Escalate significant compliance, safety, or operational concerns to Longeviti leadership.

Data, EDC, and Imaging Workflow Management

• Help implement and manage REDCap or a similar electronic data capture system.
• Ensure study forms, validation checks, timestamps, data locks, audit trails, and reporting tools support protocol requirements.
• Track completeness and quality of case report forms across participating sites.
• Coordinate with sites on study data transfer, de-identification, documentation workflows, and secure data storage.
• Where applicable, support imaging-related workflows, including image tracking, site coordination, de-identification, and linkage of study data by participant or study ID.
• Support creation of study dashboards and operational reports for enrollment, data completeness, follow-up status, deviations, adverse events, and site performance.

Project Management

• Build and maintain a structured clinical operations project plan using Microsoft Planner or a comparable project management system.
• Create clear workstreams for site startup, IRB submissions, contracts, training, enrollment, monitoring, data management, imaging transfer, and closeout.
• Maintain action-item logs, responsibility assignments, due dates, risk trackers, and escalation pathways.
• Coordinate recurring internal and external study meetings, prepare agendas, document decisions, and follow up on action items.
• Use Microsoft Teams, SharePoint, Excel, Planner, and related Microsoft 365 tools to organize study communications and documentation.
• Preference will be given to candidates with experience using Microsoft Planner, Microsoft Project, Smartsheet, Asana, Monday.com, or similar project management tools in a clinical research, medical device, healthcare, or life sciences environment.

Required Qualifications

• Bachelor’s degree in life sciences, clinical research, nursing, public health, healthcare administration, or a related field.
• 5\+ years of experience in clinical research operations, clinical trial management, site management, clinical project management, or sponsor/CRO operations.
• Experience managing multi-site clinical research studies.
• Direct experience with IRB submissions and regulatory documentation.
• Working knowledge of Good Clinical Practice, informed consent, regulatory documentation, protocol deviations, adverse event reporting, monitoring, and study closeout.
• Experience working with academic medical centers, hospital research offices, investigators, and clinical coordinators.
• Strong organizational skills and ability to build operational systems from scratch.
• Excellent written and verbal communication skills.
• Ability to work independently in a fast-moving, lean company environment.
• Proficiency with Microsoft Office, Excel, Teams, SharePoint, and project management tools.
• Willingness to work primarily in person or in office, with travel to clinical sites as needed.

Preferred Qualifications

• Experience with WCG central IRB or similar central IRB platforms.
• Experience with REDCap or similar electronic data capture systems.
• Experience with medical device, imaging, neurosurgery, neurology, neurocritical care, trauma, stroke, or hospital-based research.
• Experience managing observational studies, diagnostic accuracy studies, registries, post-market studies, or investigator-initiated studies.
• Prior experience as a Clinical Research Associate, Clinical Study Manager, Clinical Project Manager, or Clinical Operations Manager.
• Familiarity with imaging workflows, PACS, DICOM files, de-identification, or imaging repositories.
• Experience supporting or monitoring studies involving academic medical centers or surgical specialties.
• Experience working in a startup, emerging growth company, or other resource-constrained environment.
• Certification such as ACRP-CP, CCRC, CCRA, CCRP, PMP, or equivalent is a plus.

Success Measures

Within the first 90 days, the Clinical Research Manager should be able to:

• Establish a comprehensive operational plan for active and upcoming Longeviti-sponsored studies.
• Map responsibilities across Longeviti, clinical sites, IRBs, vendors, and external collaborators.
• Build site activation, IRB, enrollment, follow-up, monitoring, and closeout trackers.
• Confirm IRB pathway and submission status for participating sites.
• Identify gaps in site readiness, regulatory documentation, data capture, and study workflows.
• Establish a recurring cadence for internal study updates and site-level follow-up.
• Implement a project management structure using Microsoft Planner or a comparable tool.

Longer-term success will include:

• Timely site activation and enrollment support.
• High-quality, complete, and audit-ready study documentation.
• Reliable tracking of study procedures and follow-up completion.
• Effective management of protocol deviations, adverse events, data queries, and monitoring findings.
• Clean study closeout across participating sites.
• Creation of a repeatable internal clinical operations model for future Longeviti-sponsored studies.

Travel

Travel to participating clinical sites, investigator meetings, or study-related meetings may be required. Anticipated travel will vary by study phase and site needs.

Equal Opportunity

Longeviti is an equal opportunity employer. We are committed to building a diverse and inclusive team and encourage qualified candidates from all backgrounds to apply.