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Cordis · 5 months ago

Manager, Field Clinical Research (Remote)

United States

Full-time

Remote

Senior Level, Lead/Staff

8+ years exp

Cordis is a company specializing in the development of advanced drug device combination products for coronary and peripheral artery disease. They are seeking a Manager, Field Clinical Research to provide case support to physicians, manage a clinical field research team, and ensure the quality and compliance of clinical studies.

Health CareHealth DiagnosticsMedical

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

Qualification

Clinical research experienceCardiovascular proceduresClinical trials experienceClinical PracticeRegulatory compliancePhysician trainingData entryTeam managementCommunication skills

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