Sr. Clinical Specialist

JOB DESCRIPTION:

Leading an active lifestyle is important to the many people we serve. In Abbott’s Electrophysiology division, we’re advancing the treatment of heart disease through breakthrough medical technologies in electrophysiology, allowing people to restore their health and get on with their lives.

We are seeking an experienced, high caliber Field Clinical Specialist. This position will be primarily responsible for demonstrated and consistent technical and clinical support to the Clinical Affairs Organization, with specific focus on BU technologies and therapy areas. This individual will provide field support of clinical research study procedures with Abbott BU technologies, as well as, accurate technical support/troubleshooting, project and/or territory management, general field image representation for Abbott, and field input to BU product management groups. Will function as an expert resource for covering clinical studies/procedures, handling challenging technical/protocol troubleshooting scenarios, critical software or product testing, product or project advisory boards, and high-profile presentations while collaborating with the sites and other cross functional partners on BU clinical studies.

Job Duties:

WHAT YOU’LL DO

• Provide field support for clinical research related enrollment and procedures in specified therapy area.
• Serve as a technology, protocol and clinical trial procedure expert and resource to Abbott stakeholders, physicians, and research personnel at the site.
• Proactively, and with minimal oversight, maintain and develop a productive clinical territory:
  • Develop and maintain knowledge of clinical sites in the assigned territory.
    • Understand and assess investigators’ interests and qualifications.
    • Identify appropriate investigators as defined by study-specific requirements and by the applicable regulatory code.
    • Maintain open communication and relationships with key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel.
  • Use critical thinking to identify issues, address them, and create plans to augment success or prevent recurrence of variances from site expectations.
    • Facilitate communication between clinical sites and other Abbott clinical staff (e.g., CSL, CRA, study team, Contracts Associate), as needed.
  • Work with sites to develop capabilities to take on more complex trials, or larger volume of trials.

• Manage the following aspects of study progress:
  • Start Up
  • Nominate, approach, and complete qualification processes including establishing site/sponsor expectations for study execution.
  • Facilitate contract/budget escalations as part of the start-up process.
  • Train facility staff regarding protocol requirements and technology.
  • Enrollment
    • Develop site-specific strategies to promote appropriate patient enrollment.
    • Identify site successes and challenges and assist in implementing troubleshooting techniques that promote study goal achievement.
  • Provide ongoing feedback concerning all aspects of study progress, specifically enrollment and procedure related, for the purpose of developing and implementing strategies that will optimize patient safety and contribute to organizational and corporate goals/objectives.
  • Provide support for all study-related aspects to research partners, including but not limited to the following questions: technical, protocol, standard of care, clinical trial reimbursement, etc.

• Responsible for product reporting and troubleshooting with customers and field personnel within the BU clinical research portfolio
• Work with territory Clinical Site Leads to share best practices and develop capabilities to optimize trial data quality
• Collaborate with and provide feedback to Clinical Scientists, study teams, and Clinical Site Leads on study design and procedure and product experiences.
• Identify and communicate best practices relevant to clinical trial execution.
• Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities.

• Collaborate with Clinical Affairs, Medical Affairs, R&D, marketing, and commercial teams to support and advance key BU projects.
• Serve as a scientific interface with healthcare professionals.
• Act as resource in corporate product education as it relates to investigative technologies, as necessary: development and review of training materials, presentations, regional and national product launches, and BU commercial field education.
• Develop collaborative cross-divisional team relationships.
• Function as a “pipeline” between Abbott and the medical community, constantly communicating important information to customers, within the Clinical Affairs group and to other departments (product planning, med affairs, engineering, marketing and education). This includes providing product feedback, comments and suggestions and Competitive information to the Product Planning and Marketing groups.
• Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

• Identify and share best practices for territory management.
• Deepen area(s) of expertise and function as a regional clinical and technical resource.
• Utilize effective communication skills in difficult conversations with key stakeholders.
• Contribute additional value to the organization beyond primary responsibilities which may include but are not limited to:
  • Actively seek opportunities to deliver value on a national level.
  • Serve as a study champion.
  • Provide feedback on product performance.
  • Act as a mentor to other FCS staff.

EDUCATION AND EXPERIENCE YOU WILL BRING

Everything from “Field Clinical Specialist” Job Description plus:

• Bachelor’s Degree in engineering, biological sciences, or a related field, OR equivalent or related experience in cardiology or clinical research.
• 3 or more years of progressively more responsible relevant clinical work experience in the cardiovascular field.
• High level of competency in cath lab and operating room protocol and procedures.
• Recognized as a leader/expert beyond local territory
• Ability to travel approximately 60%, including internationally.
• Highly competent English Skill

The base pay for this position is

Originally posted on Himalayas