Field Clinical Specialist
vor 3 Monaten
**Field Clinical Specialist - Abiomed**:
**ABIOMED part of Johnson & Johnson, **is an innovative medical device business with an inspiring mission "Patients First," and a unique guiding company principle " Recovering hearts. Saving lives." With more than 2,000 employees, Abiomed is one of the fastest growing medical technology businesses in the world with corporate headquarters in Danvers, USA, and locations in Aachen and Berlin, Germany, Tokyo, Japan, and Singapore. Abiomed is part of Johnson & Johnson MedTech.
**ABIOMED** is an employer with attractive working conditions and an appreciative corporate culture that focuses on the needs of its employees. Abiomed inspires and retains exceptional talent through collaboration, passion and continuous development.
**Role Purpose**:
We are seeking an experienced Field Clinical Specialist EMEA responsible for outstanding clinical trial execution at Abiomed to optimize patient safety, trial enrollment, and sustain data integrity. Collaborating cross-functionally with Abiomed stakeholders and leveraging strong relationships with clinical site personnel including physicians, nurses, and clinical research specialists, the Field Clinical Specialist supports site selection and startup, drives patient recruitment, ensures protocol and data compliance, provides technical support for clinical procedures, supports challenging technical/protocol troubleshooting scenarios, critical software or product testing, and site closeouts.
**What you will expect**:
- Provide field support for clinical research related enrollment and procedures.
- Serve as a protocol and clinical trial procedure expert and resource Abiomed stakeholders, physicians, and research personnel at the site while maintaining a strong background on technology and clinical standards.
- 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.
- Proactively and critically examine ways to enhance overall clinical trial performance.
- Facilitate communication between clinical sites and other Abiomed clinical staff (e.g., CRA, study team, Contracts Associate), as needed.
- Manage the following aspects of study progress, including, but not limited to:
Start Up- Nominate, approach, and support 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.
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.
- Responsible for product complaint reporting and troubleshooting with customers and field personnel within the clinical research portfolio.
- Collaborate with and provide feedback to Clinical Scientists and study teams in the development of clinical study deliverables, such as protocol design, source documentation, work instructions, patient recruitment materials and product training.
- Identify and communicate best practices relevant to clinical trial execution.
- Seek opportunities to continue demonstrating and developing technical, research, and organizational leadership qualities.
- Develop collaborative cross-divisional team relationships with Clinical Affairs, Medical Affairs, R&D, marketing and commercial teams where required to support and advance key projects.
- Transfers clinical trial knowledge and experience into meaningful input and feedback to cross-functional partners.
**Qualifications**:
**What you will have**:
- Bachelor’s Degree in engineering, biological sciences, a related field, equivalent or related certification in cardiology or certified nurse, perfusionist or similar.
- Typically, a minimum of 5 years of relevant clinical experience, with in-depth knowledge of cardiology, and related cardiovascular technologies
- Direct patient support in Cath lab or OR is a plus
- Background in the execution of clinical studies is a plus
- Availability for emergent patient care required
- Ability to work in a highly matrixed and geographically diverse business environment.
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