Rivanna Medical
The Clinical Study Manager typically oversees the execution of clinical studies, ensuring compliance with protocols, managing study timelines, coordinating with research sites, and maintaining regulatory documentation. They work closely with sponsors, investigators, and regulatory bodies to ensure studies meet safety and efficacy standards. The successful candidate will serve as the primary point of contact for study operations, ensuring studies are conducted in compliance with regulatory requirements and company standards.
Responsibilities
Overall management, integration, and coordination of clinical study activities, including technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of RIVANNA's multi-site clinical activities. Proactively track and manage clinical development tasks against timelines and budgets. Prepare clinical study status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders. Engage with internal commercial, research and development, and manufacturing teams to ensure successful planning, coordination, and execution of clinical research work packages. Participate in preparing and reviewing study documentation, develop and maintain comprehensive study plans, including site selection strategies and enrollment projections 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. Conduct regular study team meetings and provide status updates to senior management and sponsors. Irregular travel for conferences or to visit clinical sites is anticipated. Subcontract management such as CROs and Medical Advisory Committees. 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.
Responsibilities
Overall management, integration, and coordination of clinical study activities, including technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of RIVANNA's multi-site clinical activities. Proactively track and manage clinical development tasks against timelines and budgets. Prepare clinical study status and progress reports, maintaining accurate and current details for communication to internal and potentially external stakeholders. Engage with internal commercial, research and development, and manufacturing teams to ensure successful planning, coordination, and execution of clinical research work packages. Participate in preparing and reviewing study documentation, develop and maintain comprehensive study plans, including site selection strategies and enrollment projections 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. Conduct regular study team meetings and provide status updates to senior management and sponsors. Irregular travel for conferences or to visit clinical sites is anticipated. Subcontract management such as CROs and Medical Advisory Committees. 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.