Clinical Research Manager

Job Description:

The Clinical Research Manager will lead and support clinical operations across multiple indications and geographic regions, including the United States, Europe, and the United Kingdom. This individual will be responsible for the overall operational management of clinical studies, including planning, execution, oversight, and cross-functional coordination, to ensure trials are conducted in compliance with applicable regulations, study protocols, timelines, and corporate objectives.

In addition to overseeing day-to-day study operations, the Clinical Research Manager will play a key role in developing and maintaining strategic relationships with surgeons, clinical staff, hospital administrators, and research partners. These relationships will support collaboration opportunities, site identification and qualification, and recruitment of new Principal Investigators and study centers. The role may include oversight of internal Clinical Research Associates and/or external contract research organizations (CROs), with responsibility for ensuring high-quality monitoring, site performance, and consistent study execution.

This role requires a balance of operational leadership and external engagement. The successful candidate will develop a strong knowledge of Rev Bio’s product portfolio and clinical applications and will be responsible for ensuring sites are appropriately trained and supported on study protocols, investigational use requirements, and study procedures. They will oversee study-specific compliance, data collection progress, site performance, monitoring activities, and issue escalation and resolution, while supporting regulatory submissions and facilitating effective communication between study sites and Rev Bio headquarters.

The Clinical Research Manager will also represent Rev Bio at scientific and medical meetings, support the preparation and presentation of clinical and scientific materials, and contribute to manuscripts, abstracts, and grant applications as needed. This individual will be expected to proactively engage with the surgical and research communities to expand Rev Bio’s clinical network, strengthen the company’s credibility, and support the growth of its clinical efforts in the United States and internationally.

• Interface with Rev Bio leadership, internal technical teams, and advisory clinical subject matter experts to develop a deep understanding of the clinical, scientific, and operational requirements for successful application of Tetranite in each indication under investigation.
• Lead the planning, execution, oversight, and continuous improvement of clinical studies across multiple indications and geographic regions.
• Oversee study startup, site activation, enrollment progress, study conduct, and closeout activities to ensure alignment with protocol, timelines, budget, and regulatory requirements.
• Provide oversight of site training on study protocols, investigational product use, and applicable Instructions for Use (IFU), ensuring consistency and quality across all participating sites.
• Oversee data collection progress, monitoring activities, protocol compliance, and issue escalation to ensure high-quality study execution.
• Review study metrics, site performance, monitoring findings, and data quality trends, and implement corrective actions as needed.
• Ensure investigators and site personnel are appropriately supported to complete EDC entries, data uploads, query resolution, and required study documentation in a timely manner.
• Oversee payment approval processes and confirm alignment between site activity, product delivery, milestone completion, and data submission.
• Support and contribute to the preparation and submission of clinical trial protocols, informed consent documents, investigator materials, and regulatory documentation required to initiate and maintain clinical studies, including amendments and supplements.
• Support and contribute to ethics committee and IRB submissions, renewals, supplements, and amendments as applicable.
• Ensure comprehensive, inspection‑ready documentation is maintained for…