Senior Manager, Field Clinical Research (Remote)
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Senior Manager, Field Clinical Research (Remote)
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Senior Manager, Field Clinical Research (Remote)
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Job Summary:
Cordis, in partnership with Selution, is focused on developing innovative technology for advanced drug-device combination products aimed at treating coronary and peripheral artery diseases. The Manager, Field Clinical Research plays a vital role in providing case support for clinical studies, managing a team, and ensuring the quality and compliance of clinical research activities.
Responsibilities:
• Manage and build a world class CFS team
• Ensure case coverage by utilizing site assignments and triaging case support
• Ensure processes and procedures that protect the quality of our clinical studies
• Perform Physician and hospital staff training and procedural case coverage to ensure safe and effective use of the device
• Present clinical study training materials based on investigational plans including study protocol, IFU, core lab manuals and case report forms
• Provide field support for clinical studies by participating in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities
• Address clinical research site needs by maintaining frequent contact via email/phone/on-site visits with PI's and research coordinators
• Responsible for gaining and maintaining knowledge of clinical sites in a given geographical area to best understand and assess investigators interests and capabilities
• Manage key study sites (investigators and research staff) and serve as 'live' point of contact with the site for communication with SELUTION CSM, CRA, and CRO team
• Partner with SELUTION clinical research teammates to meet business needs in the field including site CIP questions, re-training, case coverage, data entry/query resolution and escalation of critical issues
• Administrative activities including evaluating metrics, data entry into trackers, documentation of activities and site feedback to SELUTION study teams
• Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies
• Identify and mitigate quality risks and issues for assigned clinical studies with oversight from study management team
• Assist with oversight of activities performed by CRO
• Maintain in-depth knowledge of current study protocols, process and procedures to assist sites and facilitate study management team efforts
Qualifications:
Required:
• Bachelor’s Degree in a life science, nursing, engineering, or healthcare related field
• Minimum 8 years’ experience with cardiovascular procedures in clinical research in this same role or as a nurse or tech as radiology tech or cath lab tech
• Minimum 8 years’ experience working directly with physicians and healthcare professionals
• Experience in coronary or peripheral interventions
• Experience with Good Clinical Practice (GDP) and/or regulatory compliance guidelines for clinical studies
• Ability to travel (at least 75%) to company and clinical trial sites
Preferred:
• Prior experience with clinical trials
Company:
Cordis Corporation, a Johnson & Johnson company, has pioneered less invasive treatments for vascular disease. Founded in 1959, the company is headquartered in Hialeah, Florida, USA, with a team of 1001-5000 employees. The company is currently Late Stage.
Seniority level
Seniority level
Mid-Senior level
Employment type
Employment type
Full-time
Job function
Job function
Product ManagementIndustries
Software Development
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Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
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