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  employees. The company is currently Late Stage.

• Seniority level
  
  Mid-Senior level

• Employment type
  
  Full-time

• Job function
  
  Product Management
• Industries Software Development

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Medical insurance

Vision insurance

401(k)

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