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Welch Allyn Vision Care Clinical Research Senior Specialist

JOB SUMMARY:
This position will serve as the clinical expert with primary focus on the Vision Care product lines interacting with marketing, regulatory, and research & development to ensure clinical activities are aligned with business objectives. This role's 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.
KEY RESPONSIBILITIES:
Develop clinical evidence plans and protocols to support market adoption for new and existing products including demonstration of health economics, improved outcomes, increase efficiency, or other customer benefits of adoption. Deliverables may include clinical studies, dossiers, ROI models or other tools that support the sales process. 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 studies.
Establish relationships with key thought leaders and investigators to seek guidance & validation of clinical plan and study protocols.
Share clinical insights with new project development teams in an advisory role as a clinical expert for Vision Care.
Assist with development of 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 subject matter expert (SME) of the portfolio and developing/managing relationships with key opinion leaders (KOL).
REQUIRED BACKGROUND:
BS/BA in a related medical, science or business discipline; RN/ BSN or ophthalmology experience preferred.
Experience with clinical research 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.
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