Senior Field Clinical Specialist - Eastern US

About the job

As a Senior Field Clinical Specialist, you will play a vital role in supporting the execution of clinical studies on-site, collaborating closely with hospital staff, including implanting surgeons, SCI rehabilitation clinicians, and various study partners. Acting as the crucial link between healthcare facilities and our company, you will enhance our understanding of SCI and neurological rehabilitation practices. Your primary responsibilities include building and maintaining strong relationships with investigational sites as we execute a global pivotal study, providing comprehensive technical support, and ensuring the highest level of compliance and adherence to Good Clinical Practice (GCP) standards.

Responsibilities

• Implement and coordinate clinical study activities in hospitals within your respective region, ensuring a seamless and efficient execution of study protocols.

• Provide technical, clinical, and neuromodulation programming assistance, staff education, and technical troubleshooting.

• Assist in the training of sites and study staff on technical aspects of the study protocol and procedures.

• Assist sites with pre-screening activities to ensure appropriate candidates for study inclusion.

• Proficient in complex therapy programming, implant case support.

• Assist in after-hours call support and activities.

• Provide feedback to providers both within operating room setting and outside operating room setting on the directions for use specific to implantable devices.

• Foster high-trust relationships with customers, including the regional team members.

• Collaborate with clinical study centers and the ONWARD medical clinical operations and regulatory team to guarantee the smooth enrollment of subjects and maintain the highest quality data collection in accordance with GCP requirements.

• Work closely with study vendors, such as Contract Research Organizations (CROs), to coordinate site-level activities and facilitate timely compliance with study protocol procedures, as well as the accurate reporting of data.

• Collaborate with the Product Development team to facilitate the transfer of comprehensive technical knowledge to the clinical team and study centers. Conversely, contribute by bringing valuable insights from rehabilitation practices, clinical expertise, and user feedback back to the company.

• Manage efficient device-related Quality reporting.

• Document any key compliance actions.

• Provide hands-on technical and clinical training and support on-site during study-related surgical operations or rehabilitation procedures, ensuring the safe and effective use of medical devices.

• Maintain current knowledge and comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Good Clinical Practices (GCP), Company policies, operating procedures, processes, and task assignments.

About You

• Bachelor’s Degree or technical certification; engineering degree preferred, or other advanced or medical degree.

• Patient interaction experience within healthcare related environment (Physical Therapy, medical product sales, RN, LPN) preferred.

• A minimum of 3 years’ proven experience in clinical field activities and direct interactions with physicians in operating room environments, including engagement with Key Opinion Leaders.

• Intraoperative neuromonitoring (IONM) experience is a plus

• A minimum of 3 years’ experience with spinal cord stimulation (SCS) setting or with another implantable medical device company. Experience in neurological rehabilitation is a plus. 

• Experience with SCS surgical paddle lead implant and programming is a plus.

• Capable of working unpredictable schedule that may occasionally change on short notice due to operating room schedule changes and/or delays.

• Strong sense of urgency toward issue resolution.

• Demonstrated experience in conducting clinical research studies, ideally involving pre-market implantable (IDE) studies, while adhering to Good Clinical Practice (GCP) standards.

• Exhibit meticulous attention to patient safety and a steadfast commitment to compliance with study protocols.

• Excellent organizational, time management and prioritizing skills.

• Excellent interpersonal verbal, written and presentation skills with ability to effectively communicate at multiple levels and to large groups within and outside the organization.

• Experience using Microsoft Office tools (Word, PPT, Excel) to create technical documentation, training materials, and data organization.  Experience delivering those materials to a multidisciplinary audience (e.g., both internal company-facing and external clinic-facing).

• Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

• Fluent communication in English, both spoken and written.

• Strong attention to detail to facilitate accurate data collection and documentation and delivery of technical learnings.

• Display interest in working with innovative medical device technologies in an international environment and within the clinical field.

• Innately curious about the scientific basis of our learnings; driven to always ask “why?” and share learnings with teammates.

• Maintain an attitude compliant with the high-quality and regulatory requirements associated with Class III medical devices.

• Ability to travel 75% within assigned region and/or outside assigned region, including occasional international travel.  Primarily flying, some driving if located in same city as study site.

• Preferably located in airline hub city (Baltimore/DC, Boston, NYC, CLT, RDU, Chicago) to facilitate ease of travel requirements.

• ONWARD CODE Representation: Embody the core values of ONWARD, including being empowered, committed, pragmatic, innovative, open, trusting, collaborative, and passionate.