Job Description

The Clinical Project Manager is responsible for independently initiating, managing, and completing moderately complex clinical projects with minimal supervision. This role involves overseeing project timelines and deliverables, managing budgets, and applying established project management practices to ensure program success. The ideal candidate is proactive, organized, and capable of driving cross-functional collaboration to meet clinical and operational goals.

Responsibilities

• Overall management, integration, and coordination of all clinical program activities, including technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all clinical activities.
• Proactively track and manage clinical development tasks against timelines and budgets.
• Prepare clinical project status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders.
• Coordinate communication and clinical project activities against program milestones and deliverables.
• Engage with internal commercial, research and development, and manufacturing teams to ensure successful planning, coordination, and execution of clinical research work packages.
• Responsible for development of clinical evidence generation plans and execution.
• Perform medical and scientific review of clinical related content including scientific literature, clinical study protocols, informed consent forms, investigator brochures, case report forms, clinical study reports.
• Participate in preparing and reviewing study documentation, competitive landscape research and feasibility studies for new proposals as required.
• Oversee and track progress of site identification, start-up, monitoring, and study close-out activities, including managing third-party vendors and / or contract CROs.
• Establish relationships with investigators and KOLs and maintain engagement with KOLs and stakeholders.
• Irregular travel for conferences or to visit clinical sites is anticipated.
• Subcontract management such as CROs and Medical Advisory Committees.
• Develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all program data.
• Lead clinical statistical analysis efforts and understand how to appropriately power a study for its endpoint result.

Requirements

• MS, PhD degree in science, or related field with clinical research experience of 5 years minimum preferred.
• Minimum 7 years of experience in clinical research and 2 years of leading clinical research studies preferred.
• Experience with medical device technology and clinical studies or trials.
• Understanding of FDA medical device regulations and medical device reimbursement.
• Excellent scientific communication skills, both verbally and written.
• Strong scientific rigor and data analysis skills.
• Demonstrated ability to set and meet tight deadlines and function well under pressure..
• Strong leadership and interpersonal skills with ability to effectively engage external stakeholders and build lasting relationships

About Rivanna Medical, Inc.: RIVANNA® is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA. RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro® product line and related medical equipment and components. Accuro is the world's first spinal navigation device designed to improve the safety, speed, and efficiency of spinal needle guidance procedures. Rivanna Medical, Inc.'s revolutionary platforms feature BoneEnhance® Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D™ AI-Based Spine Recognition, which automates ultrasound image interpretation.

Employee Benefits at Rivanna Medical, Inc.: Rivanna Medical, Inc. offers a comprehensive benefits package, which includes health insurance, vision and dental coverage, group life insurance, long-term disability insurance, paid time off, a 401(k) plan with company match, and more. We are continually seeking to enhance our team with individuals who bring unique perspectives and experiences. This diversity of thought and perspective drives innovation and strengthens our commitment to creating an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

Equal Employment Opportunity Statement: Rivanna Medical, Inc. is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, or any other protected status in accordance with all applicable federal, state, and local laws. All employees must be able to lift at least 25 pounds. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of their positions.

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