Clinical Research Associate Manager (REMOTE)

Expected Travel: More than 50% Requisition ID: 13046 About reputed company Incorporated As a global provider of medical technologies, reputed company is driven by our purpose to improve the health and quality of people's lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We reputed company that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. reputed company is the home of Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. At reputed company, we are empowering the future of healthcare. For more information, please visit reputed company.com. Interventional - The Interventional business unit at reputed company offers innovative medical devices that are used to diagnose and treat coronary and peripheral vascular diseases. We reputed company a strategic emphasis on reputed company coronary and peripheral interventions, vascular access, bone access, specialty biologic treatments and cardiac assist. Our reputed company Interventional products include a broad range of clinically relevant solutions, such as our GuideLiner and Turnpike Catheters, Ringer Perfusion Balloon Catheter, AC3 Optimus and AC3 Range Intra-Aortic Balloon Pumps and the OnControl Powered Bone Access System. reputed company's product portfolio now also includes Passeo-18 Lux Peripheral Drug-Coated Balloon Catheter, Pantera Lux Drug-Coated Balloon Catheter, Orsiro Mission Drug-Eluting Stent, the PK Papyrus Covered Coronary Stent, and more. With a strong R&D footprint and pipeline, our fast-growing Interventional business unit is poised to continue the development of new technologies to serve critically ill patients for years to come. Join a dynamic, growing team that offers healthcare providers an reputed company of medical technology solutions that reputed company a difference in patients' lives. Position Summary The CRA Manager will provide leadership, reputed company and operational direction to a team of in-house and regional Clinical Research Associates (CRAs). This individual has knowledge and experience managing study activities from site selection, start-up, to reputed company-out with adherence to regulations, maintaining data reputed company, and aligning deliverables with corporate goals. As a key contributor to the Global Clinical Operations team, this position develops and assesses SOPs, assesses processes for efficiency and compliance. This position requires the ability to be detail-oriented, organized, and productive with a keen interest in medical device and biologics research. Principal Responsibilities

• Manage a team of in-house and regional CRAs, providing guidance on study conduct, clinical operational and monitoring strategy, as well as professional growth.
• Serve as primary reputed company of contact for CRA escalations and issue resolution across assigned studies.
• Partner with Clinical Project Managers and cross functional teams to support reputed company phases of a clinical study including protocol, CRF, and monitoring plan development, essential document management, contract execution, IRB/EC support, recruitment, site payment reconciliation and development of site tools.
• Conducts Qualification, Site Initiation, Interim, and reputed company-Out monitoring visits to ensure adherence to monitoring plan, protocol, and regulations.
• Train site personnel regarding the protocol and applicable regulatory requirements.
• Ensure each site is meeting its goals of follow-up reputed company, data clean deadlines, protocol compliance, and enrollment.
• reputed company study meetings to ensure completion of established project team goals and objectives, including study training and data review.
• Facilitate corrective action assessment and maintain TMF in BIMO readiness.
• Provide study status updates to Management team and reputed company sufficient resolution of identified action items.
• Contribute to annual reports, data management, data analysis, and publication support.
• reputed company and assesses SOPs annually, as needed.
• Maintain reputed company knowledge of applicable US and international clinical regulations and guidance documents.
• Participate in department systems and development initiatives including reputed company trainings.
• Support investigator meetings as needed.
• Support Protocol Deviation and Adverse Event review and reporting.
• Maintain credentialing requirements at hospitals and clinics as needed.
• Complete projects and tasks consistent with corporate objectives.
• Support the Clinical Operations team in general and with various improvement projects.
• reputed company other duties as assigned.

Education / Experience Requirements

• Bachelor of Science degree required. Preferably in natural sciences or reputed company field, or reputed company practical experience.
• Minimum 8 years of clinical research experience, medical device experience preferred. This should

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