Senior Manager, Field Clinical Research (Remote)

Jobright.ai

Irvine (CA)

Remote

USD 76,450 - 102,300

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

Jobright.ai seeks a Senior Manager for Field Clinical Research to oversee clinical study activities and manage a high-performing team. The role requires extensive experience in cardiovascular clinical research, strong communication skills with healthcare professionals, and the ability to ensure compliance with clinical standards. Candidates should possess a bachelor's degree in a relevant field and be willing to travel frequently to study sites.

Qualifications

Minimum 8 years’ experience with cardiovascular procedures in clinical research.
Experience in coronary or peripheral interventions.
Ability to travel (at least 75%) to company and clinical trial sites.

Responsibilities

Manage and build a world-class clinical field support team.
Ensure quality and compliance of clinical research activities.
Support clinical studies through training and case management.

Skills

Clinical Research Experience

Cardiovascular Procedures

Good Clinical Practice

Regulatory Compliance

Communication with Healthcare Professionals

Education

Bachelor’s Degree in a life science, nursing, engineering, or healthcare related field

Job description

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