This position will serve as the clinical expert with primary focus on the Vital Signs & Cardio product lines interacting with marketing, regulatory, and research & development to ensure clinical activities are aligned with business objectives. Objective is to create strong clinical evidence to drive market adoption and serving as a clinical workflow and subject matter expert for the assigned categories of products.
· Develop clinical plans and protocols for new and existing products through strong cross-functional engagement and sharing clinical insights to Early Innovation and NPD projects as well as risk assessments in an advisory role.
· Design clinical projects to collect outcomes data supporting market adoption, new product approvals, and reimbursement. This includes various forms of research such as review articles, health outcomes data, post-marketing studies, and clinical trials.
· Establish relationships with key thought leaders and investigators to seek guidance & validation of clinical plan and study protocols.
· Develop clinical project plans including key milestones, budget needs, and resource deployment (i.e. internal sources, clinical research organizations (CRO), and institution on site staff).
· Conduct clinical studies including with responsibility for the following:
- · Identification of appropriate sites/investigators.
- · Qualifying, enrolling and training investigators and investigator’s site personnel in study protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements. Conduct product training & set up with intended users prior to clinical study
- · Monitoring study progress, preparing study documents and providing updates on study status.
· Establish and manage publication plans to ensure high impact dissemination of clinical content.
· Travel to key thought leaders, clinical trial sites, and key scientific meetings/tradeshows (25%).
· Responsible for being a SME of the portfolio and developing/managing relationships with key opinion leaders.
BS/BA in a related medical, science or business discipline; RN/ BSN Preferred
· 6-8 years of experience leading clinical programs in medical device or pharmaceutical industries.
· In-depth knowledge of clinical research programs including methodologies, processes, and timelines.
· Experience in the planning, conducting, and managing studies in a clinical program from study start-up to regulatory submission.
· Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.
· Strong cross-organizational collaboration with internal teams and external investigators or project partners.
· Detail oriented with strong analytical skills and expertise in searching medical literature and databases for clinical and technical information.
· Strong organizational skills with ability to multi-task and manage multiple projects in parallel.