Denise Neuheimer Email & Phone Number

Cary, North Carolina, United States

Madison, Wisconsin, United States

● Analyzed and created plan to support 21 Imaging Quality Control Specialists (IQCS) in 110+ clinical research trials. Utilized medical device industry relationships that are well established to assist escalations or when appropriate - assist in sales needs. ● Directed and elevated IQCS team by using leadership to create essential structure. Set expectations that increased communication and productivity 300% in OCT segmentation analysis and 30% overall vs. prior year to meet scale of business● Launched coordination of SSU meetings between PM and IQCS team in study to ensure cross functional details were communicated, IQCS team is informed on study, ensured fulfillment of training requirements for regulatory compliance prior to assigning the team member(s) in active or newly configured studies.● Utilized ophthalmic knowledge base to offer guidance on medical device camera selection vs. goals of study● Review or create imaging procedures for technical imaging parameter analysis and practical design prior to it being sent to sponsor for sign off● Reviewed tools for analysis and secured internal coding expert to build new tools and update existing tool with new modalities and new IQCS team members allowing to effectively analyze different types of work performed. ● Managed volume of needs by creating a workload allocation forecast● Collaborated with PM leadership to evaluate scope of work vs. budget, studies were meeting TAT’s for study/sponsor expectations● Managed data by identifying, creating and or completing non-comformance events and CAPA. Used SOP’s, GDP and GCP along with quality assurance team guidance to drive documentation to completion.

Pleasanton, Ca

• Trained pediatric ophthalmologists and neonatal nurses for imaging high risk patients • Mentor trainees to gain certification in Regeneron and Bayer clinical research trials• Developed training process and content for virtual training carried out through pandemic • Administrator for pediatric telemedicine project with time sensitive needs

Morrisville, Nc

• Collaborated with product management, regulatory, R&D, marketing, and sales teams on new products to develop relevant clinical content used in creation of training and marketing materials.• Developed train-the-trainer material, delivered formal classes and hands-on training in operating room on global scale to prepare teams and increase sales.• Nurtured global KOL program with a focus on emerging gene therapies & new surgical techniques.• Analyzed global sales performance and developed strategies through clinical relevance • Developed and trained Regional Continental champions for EnFocus Intra-Operative OCT and Envisu Peri-Operative OCT. Traveled internationally and domestically to deliver training in operating room, clinical, and preclinical settings.Manager of Training and Biomedical Imaging, 2012-2017• Nominated and received Outstanding Achievement Award in 2017 for OCT product success. • Performed installations, clinical and pre-clinical trainings in NICU and OR, focused on research • Built internal and onsite training program.• Created and co-collaborated Standard Operating Procedures with multiple teams.• Installed capital equipment and refined training program to pair with growing product line.• Provided clinical input to R&D, software, and commercial teams by performing product development, building protocols, developing demonstration database, and communicating clinical objectives/perspective to develop business model and increase sales.

Travelled 100% and Installed Diagnostic Equipment for Glaucoma and Retinal Diseases/Disorders. Taught clinical imaging to physicians, researchers and support staff.- Performed and taught in vivo animal imaging of mice, rats, canine, rabbits and monkeys to top universities and pharmaceutical companies; assisted in their Retinal and Glaucoma research for the Dept. of Defense, Johnson & Johnson, and aspiring fellows- Product developments regularly submitted on hardware and software after thorough analysis tobuild on established product line- Performed onsite service calls for medical/capital equipment- Created and delivered national webinars related to basic clinical/diagnostic imaging and most efficient use of the equipment- Produced sales of capital equipment at annual meetings and in all regions of the country by assisting sales team to demonstrate the equipment

New York, Ny

Managed staff of five full time Ophthalmic medical photographers to support multi site Vitreo-Retinal, Glaucoma specialty practice. Extensive coverage for various sub specialties including Neurological, Cornea, Pediatric and Oculo Plastics.Heavy clinical experience utilizing 14 different types of Ophthalmic Imaging including:- Spectral Domain and Time Domain OCT (Zeiss, Optovue, Heidelberg Engineering, Topcon)- Fundus Photography, Fluroescein and Indo-Cyanine Green Angiography - Assisted Physicians with Photo Dynamic Therapy. Cameras included HRA2, Zeiss FF450, Topcon 50 EX- Operating Room assistance as needed to document new surgical procedures- Slit Lamp-Gonio, HRT, Contact Specular Biomicroscopy (confocal), Microperimetry, Retcam for pediatric use and Corneal TopographyOther responsibilities include:- Coordinate National Meetings with the Chairman (Stanley Chang, M.D.) to initiate and support research- Assisted in imaging / setting up Residents and Researchers Wet Lab specimens- Teaching the Diagnostic Imaging Specialists Levels 1, 2 and Technicians how to accurately utilize new equipment for effective clinical applications- Responsible for keeping crash cart updated and trained staff on emergency situations and day to day procedures such as blood pressures.

Atlanta, Ga

Performed Fluorescein and Indocyanine Green Angiography, Slit Lamp of Anterior Segment, Non Contact Specular Microscopy, Gonio, and assist with intricate surgical needs.Instructed Ophthalmic Technology Master Degree Candidates on Fluorescein Angiography, Collaboratively developed southeastern regional seminars, instructed photographers on stereo photography, basic fundus photography and angiography.

Hyderabad, India

- Instilled quality control regarding photographic procedures - Developed teaching aides on Diagnostic Imaging using video production for residents ␣ Fluorescein Angiography, Slit Lamp, External and Surgical Photography

B.S., B.F.A., Biomedical Imaging And Applied Photography

Good Clinical Practice, Certificate

GCP helps ensure compliance with international standards in clinical trials (ICH E6)