Clinical Research Manager

Job Description

Job Description

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 RevBio’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 RevBio headquarters.

The Clinical Research Manager will also represent RevBio 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 RevBio’s clinical network, strengthen the company’s credibility, and support the growth of its clinical efforts in the United States and internationally.

Essential Duties and Responsibilities:

Clinical Operations Management

• Interface with RevBio 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 each clinical site and study, in accordance with RevBio’s Quality Management System and applicable regulations. 
• Provide oversight of internal Clinical Research Associates and/or external CROs, as applicable, to ensure effective site management, monitoring quality, and study execution. 
• Identify study-level risks and develop mitigation strategies to address operational, compliance, enrollment, or logistical challenges. 
• Lead the investigation and cross-functional review of adverse events in collaboration with the clinical trial team, including the Principal Investigator, study site personnel, and RevBio representatives, ensuring timely assessment, documentation, escalation, and resolution. 
• Oversee the preparation of adverse event narratives, medical summaries, and adjudication packages for presentation to the Clinical Events Committee (CEC), Data Safety Monitoring Board (DSMB), and other oversight committees, as applicable.
• Perform other duties as assigned to support RevBio’s clinical development objectives. 

Site Relationship Management and Business Development

• Build and maintain strategic relationships with surgeons, clinical staff, hospital administrators, and research collaborators to support RevBio’s clinical programs and long-term growth. 
• Serve as a key RevBio representative for investigator engagement and site relationship development across assigned studies and regions. 
• Identify, evaluate, and help qualify potential new clinical sites and Principal Investigators in collaboration with RevBio headquarters and cross-functional leadership. 
• Lead or support site feasibility, site selection, site initiation, and ongoing engagement strategies to optimize study performance and partnership quality. 
• Support the development of investigator training strategies, materials, and programs for both clinical study execution and broader physician education initiatives. 
• Identify and explore opportunities for collaboration with third-party distributors, training organizations, and research partners that may expand RevBio’s clinical and commercial presence. 
• Support efforts to strengthen RevBio’s reputation, credibility, and visibility within the surgical and research communities domestically and internationally. 

External Engagement and Scientific Communication

• Represent RevBio at regional, national, and international medical conferences, symposia, advisory meetings, and professional networking events. 
• Support clinical investigators and internal leadership in preparation for scientific presentations, panels, and professional meetings. 
• Present clinical study updates, scientific data, technology developments, and related materials to external stakeholders as appropriate. 
• Collaborate on the preparation, review, and refinement of manuscripts, conference abstracts, posters, slide decks, and other scientific communications. 
• Contribute to grant applications, research proposals, and supporting documentation to secure funding for current and future clinical initiatives. 

Cross-Functional Collaboration

• Work closely with internal project leaders and cross-functional teams, including R&D, regulatory, quality, medical, and executive leadership, to ensure alignment on clinical strategy and study execution. 
• Manage communication among internal stakeholders, external vendors, CROs, consultants, and clinical sites to ensure timely issue resolution and coordinated study support. 
• Communicate surgeon feedback, site experience, and clinical performance data to internal engineering and leadership teams to support product development and clinical strategy. 
• Recommend and implement practical, creative solutions to clinical, operational, and logistical challenges encountered during study execution. 
• Support broader company objectives by contributing to initiatives that advance RevBio’s clinical, regulatory, scientific, and strategic goals.

 

Essential Education, Skills, Environment Education and Work Experience:

·       Bachelor’s degree in Engineering, Biology, Physiology, Life Sciences, or a related field required. Advanced degree preferred. 
·       Minimum 5–8 years of experience in clinical research, clinical operations, or medical device/pharmaceutical trials, preferably with increasing responsibility in study management. International study experience strongly preferred. 
·       Demonstrated experience managing clinical studies across multiple sites, indications, and/or geographic regions. 
·       Experience overseeing site performance, study timelines, and cross-functional clinical operations activities. 
·       Prior experience managing or overseeing Clinical Research Associates, contract research organizations, and/or external vendors preferred. 
·       Demonstrated ability to work independently, lead complex initiatives, and manage multiple priorities in a fast-paced environment. 
·       Strong organizational, analytical, and problem-solving skills with meticulous attention to detail. 
·       Excellent oral and written communication skills, with the ability to communicate effectively and confidently with surgeons, investigators, executive leadership, and external partners. 
·       Proficient in MS Office Suite (Word, Excel, PowerPoint), Smartsheet, Viedoc or similar EDC platforms, and project management tools. 
·       Experience supporting regulatory submissions, IRB/ethics submissions, clinical trial documentation, and inspection readiness activities preferred. 
·       Experience contributing to manuscripts, abstracts, conference presentations, and/or grant applications strongly preferred. 
·       Comfortable working with high-risk, early-stage technologies in a fast-paced, deadline-driven start-up environment. 
 
Specialized Knowledge and Skills:
·       Strong understanding of clinical trial operations, monitoring oversight, and applicable regulatory requirements across relevant geographic regions, including the United States, Europe, and the United Kingdom. 
·       Ability to work effectively in multicultural, multidisciplinary, and cross-functional environments. 
·       Demonstrated success in building and maintaining professional relationships with surgeons, medical professionals, institutions, research collaborators, and external partners. 
·       Ability to identify study-level risks, develop mitigation strategies, and drive solutions to operational and clinical challenges. 
·       Familiarity with conference participation, public speaking, investigator engagement, and scientific dissemination. 
·       Strong leadership skills, including the ability to influence without direct authority and align internal and external stakeholders around study objectives. 
·       Entrepreneurial mindset with the ability to take initiative, think strategically, and adapt quickly in a growing organization. 
·       High level of professionalism, judgment, and discretion in representing company interests internally and externally. 
·       Willingness and ability to travel extensively across the United States, Europe, and the United Kingdom, up to 50% as required. 
·       Commitment to doing what is needed to support a fast-growing start-up in achieving key clinical, regulatory, and business milestones.

Flexible work from home options available.