- Provides technical support to clinical study sites by serving as the technical resource between engineering and the medical community.
- This position is applicable when complex products are involved in clinical trials.
- Typically present during initial cardiac ablation procedure to determine how the product interacts with a human body.
- Responsible for identifying investigators, presenting protocols for a study, assisting investigators in product application, and submitting status reports on all programs.
- Support research and development in evaluating concepts of new products and modifying existing products or therapies.
- Individuals in this role are often publishing data and findings in journals and may have existing patents and/or patent applications.
- Provides all aspects of support for Clinical Research studies by identifying investigators, nominating sites, performing activation duties, providing training, encouraging enrollment, ensuring quality data acquisition and performing study closure activities.
- Responsible for gaining and maintaining knowledge of clinical sites to best understand and assess physicians’ interests and capabilities.
- Develops expertise in clinical and market released products and functions as a local technical/clinical resource for Medtronic and the customer.
- May be present in the operating room during clinical procedures as well as physician office to facilitate patient testing and data collection.
- Responsible for developing and leveraging relationships in the field to drive clinical activity and maintain focus on the customer.
- Provides feedback from clinical sites on the performance of the product to be incorporated in engineering designs or enhancements, supports research and development in evaluating concepts for new products, and considers potential modifications for existing devices while serving as a technical resource between engineering and the medical pacing community.
- Provides prospective and real-time feedback to clinical study management in study design and document development.
- Plays a critical role in educating customers, sales partners and internal Clinical Research talent on the technology that they support.
- Develop and maintain strong working relationships with “Customers” (hospital/Clinical Research center) and Medtronic field throughout territory. Independently manage relationships and all clinical and research activity at Customers within assigned territory.
- Partner with field clinical colleagues, and other Medtronic field partners, in the identification, cultivation and prioritization of study investigators/physicians.
- Facilitate/drive the research center qualification and activation processes for all Clinical Research studies in partnership with cross-functional clinical partners.
- Provide and evaluate technical and protocol training to Customers and Medtronic partners. Provide Good Clinical Practice (GCP) and/Standard Operating Procedure ( SOP) training as needed to both Customers and Medtronic partners. Assist physicians in product application, training and troubleshooting. Ensure adherence to clinical protocols.
- Provide technical support to Customers during cardiac ablation procedures and trouble-shooting as needed in support of clinical trials.
- Collaborate with Customers, sales colleagues, and cross-functional clinical partners to meet or exceed study enrollment goals. Collaborate with cross-functional clinical partners to develop enrollment tools and study management documents through input and review.
- Interpret and apply regulations and clinical standards in providing comprehensive administrative oversight across assigned Customers. Oversee clinical research data collection and protocol compliance (visit compliance/Case Report Form (CRF) completion/Monitoring action items) and work with cross-functional partners to provide corrective action, if needed.
- Provide continuous communication to cross-functional clinical partners, field research partners and sales colleagues regarding the status and performance of multiple studies within the scope of the territory.
- Actively disseminate clinical research evidence. Keep abreast of current literature, emerging science, technological developments and trends, and public database registrations on similar and competitive products
- Provide Clinical Research support across different territories and geographies.
- Work independently under limited supervision to determine and develop approach to solutions.
- Train and mentor clinical staff. May coach and review the work of other employees and manage projects/processes, requiring delegation of work.
- Develop and support individual research activities in the field by assisting physicians with research interests, drafting protocols for reviews, and supporting preparation of abstracts and/or scientific exhibits, posters and verbal presentations of accepted abstracts at key professional society meetings.
- Communicate with senior internal and external customers. Inform and become informed via an exchange of facts, statuses, ideas and issues.
- Bachelor’s degree with a minimum of 4 years of experience in clinical research/clinical specialist/clinical engineer within the healthcare industry or advanced degree with a minimum of and 2 years of experience in clinical research/clinical specialist/clinical engineer within the healthcare industry
- Advanced degree in Engineering (BioMed/EE/Mech), Healthcare/Life Sciences, or Study Management.
Clinical Research experience at Medtronic or within a medical device industry.
Experience in the management of clinical devices.
Experience in a Cath lab, biomedical engineering, hospital/clinic or medical sales.
Cardiac rhythm management device training.
Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials.
Experience in clinical studies and/or trial site management/protocols.
- Experience collaborating with cross functional clinical partners/customers, physicians and/or medical sales colleagues in the healthcare industry
- Project/Program Management expertise.
- Proficiency in MS Office applications: Microsoft Word, Excel, PowerPoint, IE.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America).
- While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.
- Ability to lift and transport heavy equipment (30+ pounds).
- Due to the possibility of exposure to radiation and infectious diseases at clinical implants, FCEs are advised to wear protective clothing, gloves and goggles at all clinical procedures.
- Ability to travel 50-75% of the time (domestic and/or internationally).