Senior Clinical Research Project Manager

Sunita Sayeram-Yoder, Ph.D.

Email: ********@*****.***

Cell Phone: 301-***-****

**** *** ****** **.

Allen, TX 75013

CAREER SUMMARY

Experienced scientific project lead with:

•Subject matter expertise in cardiovascular, oncology & ophthalmic research in preclinical and clinical trials, providing scientific consultation to clients, and developing educational outreach materials

•Experience in strategic planning, financial planning and key stakeholder communications, to successfully lead international multi-site clinical trials

•Expertise managing cross-functional teams and resources to facilitate product development and customer issue resolution (including risk anticipation & mitigation strategy), leading to greater client satisfaction

CORE COMPETENCIES

Project Management, Product Development:

•Expertise in project management integrating scientific knowledge with regulatory compliance for clinical trials, managing employees and resources toward timely project completion, as well as long- and short-range project and financial planning

•Experience with various aspects of medical device development (through research activities and regulatory submissions) and pharmaceutical industry (through work with Bayer and Biovail Contract Research); have managed cross-functional teams to develop an endoscopic OCT probe and an animal ophthalmic imaging platform that is patented

Subject Matter Expertise (SME), Scientific Methodology:

•SME in cardiovascular, oncologic & ophthalmic research, image quality optimization, and image analysis methods

•Experience in the experimental design, conduct and statistical analysis of preclinical and clinical studies

•Expertise designing, developing educational material for, and implementing customer training programs, as well as onboarding and training customers and new hires

•Experience designing experimental protocol from inception (proof-of-concept studies) to prototype evaluation and quality assessment for final product, including statistical analysis

•Expertise writing comprehensive technical reports, white papers and periodic work summaries for grants

•Experience acting as Principal Investigator (P.I.) on SBIR grant where I led a cross-functional team (of researchers and engineers) in the development of an endoscopic probe that has been implemented in well-published clinical studies for staging cartilage degeneration in osteoarthritis

•Proficiency in imaging ex vivo samples, preclinical disease models (rodents, rabbits, pigs, horse, elephant) and human patients (ranging from neonate to adult) in research, clinical & surgical settings

Customer/Stakeholder Interactions, Marketing, Regulatory:

•Experience acting as primary liaison between company and stakeholders, fostering key opinion leader relationships with researchers & developing customer loyalty, leading to greater customer satisfaction

•Experience with preparation of regulatory submissions (510(k), IND), and ensuring product and documentation compliance with regulatory standards

•Involvement in business development activities toward the expansion and enhancement of products and services, including outreach materials development

•Expertise managing customer issue resolution system, including submitting compliant documentation

EDUCATION

May 2009 Doctor of Philosophy, Major: Biomedical Engineering (Medical Imaging focus)

Dec. 2001 Master of Science, Major: Biomedical Engineering

University of North Carolina at Chapel Hill, Chapel Hill, NC

Jun. 1999 Honors Bachelor of Science, Major: Biology

University of Toronto

GRANTS

•May 2008 – Apr. 2009: Received Phase I SBIR Grant 1R43AR056194-01 as Principal Investigator for "Robust Wide-Angle Spectral Domain OCT Arthroscope for Operative Imaging and Guidance"; Total Direct Costs: $192,932

PATENTS

•Sayeram S, Vance JE, Huening P, E Buckland, Izatt JA, and GA Myers. 2012. Systems for Imaging Structures of a Subject and Related Methods. U.S. Patent 8, 240, 853, filed Apr. 30, 2010, and issued Aug. 14, 2012.

WORK EXPERIENCE

Nov. 2012 – Mar. 2017 Associate / Technical Project Manager

Booz Allen Hamilton, Rockville, MD

•Managed the efforts of my team and our subcontractors (as technical project manager (PM) on the NHLBI-funded Pediatric Heart Network (PHN)), toward addressing the interests of 23 stakeholders in a multi-site clinical trial investigating cardiovascular disease treatment outcomes

•Authored white papers, training/educational material and technical documentation (in various formats including Word, PowerPoint and Online Help), and weekly, monthly and bi-annual reports summarizing team activities, results of clinical site engagements, and reports summarizing product defects with planned fixes for the stakeholders

•Acted as SME on imaging, cardiovascular physiology, and image transfer

•Served as the liaison between the technical team and the stakeholders, and was responsible for putting out regular communications to the stakeholders keeping them informed of any product or feature updates and interruptions to their access to the PHN network

•Guided the development efforts of a technical team toward solving client issues, organizing site engagements as necessary, tracking the issues in a CRM tool, preparing test cases/plans and evaluating software versions prior to deployment

•Participated in developing financial plans for the project and managing budgeting considerations

•Was awarded a Performance and Team Award in 2015 for my efforts on PHN

•Was an active participant in Society of Women Engineers’ events, and helped organize Health Functional Community Biomedical Data Lifecycle poster fair

•Attended a number of early planning meetings of the Precision Medicine Initiative at the NIH

Feb. 2012 – Sept. 2012 Imaging Project Manager

Merge Healthcare eClinical Division, Morrisville, NC

•Acted as primary liaison between clients and company for projects involving the Clinical Imaging Management System (CIMS) and eClinical OS platforms

•Analyzed clinical trial protocols and client specifications to make recommendations on system workflows to guide system design (for clinical trial data management)

•Managed internal development and quality assurance resources to ensure that the project meets quality standards, budgetary considerations and timelines

•Provided study design and consultation services, technical support, and training for clients as needed

Aug. 2006 – Feb. 2012 Applications Engineer and Imaging Specialist

Bioptigen, Inc., Durham, NC

•Collaborated with thought leaders, researchers and physicians, providing valuable input on imaging study protocol design and data analysis

•Served as primary liaison managing key opinion leader relationships (at the FDA, NIH, NEI, NIST, US Army & major universities) & developing customer loyalty, helping to greatly expand the customer base

•Designed a formalized customer training program, developing education content such as user manuals, quick user guides and white papers, which I implemented at client sites and improved over time

•Designed research proposals; managed SBIR, NIH and regulatory (FDA 510(k)) submissions, resulting in successful awards of several grants and an FDA 510(k) clearance on our product

•Organized scientific symposia for device users at conferences; developed marketing strategies

•Was awarded SBIR grant as P.I. (leading a cross-functional team in the development of an endoscopic OCT probe used in clinical trials); developed animal ophthalmic imaging platform that is now patented

•Supported business development efforts toward the enhancement of products and services, also developing marketing outreach materials (brochures, pamphlets) in the process to generate new sales

•Managed customer complaint handling system as part of customer loyalty program I started

•Worked with researchers at military institutions such as the US Army Medical Research Detachment, and others at Military Vision Symposia, to enable them to establish research programs employing hand-held OCT

•Provided application support to customers and developed product specifications

Apr. 2006 – Apr. 2009 Doctoral Student, Emerging Imaging Technologies Laboratory

Joint Department of Biomedical Engineering

University of North Carolina at Chapel Hill, Chapel Hill, NC

•Evaluated the effects of 3D and 4D image processing methods for gated cardiac SPECT imaging of obese patients using phantom simulations & physician preference studies (using Cedars-Sinai Cardiac Suite)

•Developed and validated study tools such as an obese phantom population modeling Tc-99m tetrofosmin uptake, and a methodology for converting image format to DICOM

•Studied differences in quantitation among cardiovascular imaging methods using phantom & patient data

Jul. 2002 – Aug. 2005 Trainee, Division of Medical Imaging Physics

Johns Hopkins University, Baltimore, MD

•Evaluated the performance of several nuclear medicine cameras to find the optimal system for Indium-111 (In-111) ProstaScint® SPECT imaging studies to evaluate prostate cancer

•Developed and evaluated a phantom population for use in In-111 prostate SPECT simulation studies

Apr. 1999 – Jun. 2002 Research Assistant, Medical Imaging Research Laboratory

Department of Biomedical Engineering

University of North Carolina at Chapel Hill, Chapel Hill, NC

•Developed a detector response function (DRF) table for use in iterative image reconstruction methods for simulating tumor SPECT image formation using the Monte Carlo simulation method; evaluated DRF model using experimental phantom data and patient studies

•Contributed to the development and evaluation of a fast Monte Carlo simulation method for SPECT imaging

SKILLS

•Imaging and image processing: Various modalities (Nuclear Medicine, CT, Optical Imaging)

•Programming: C++, C, csh, HTML

VOLUNTEER EXPERIENCE

•2010: Mentor to middle-school girls in the Women and Math mentorship program in Durham, NC

•2001-2002: Developed training course materials and taught Microsoft Word to recovering addicts in the TROSA program in Durham, NC

SELECTED PUBLICATIONS AND PRESENTATIONS

•Carroll J, Dubis AM, Sayeram S, Sommer P, Patitucci T, McAllister JT, Stepien KE, Brilliant MH, Connor Jr. TB, Summers CG. Variability in foveal morphology in albinism assessed with SD-OCT. 2011; Invest. Ophthalmol. Vis. Sci. Suppl. 52: E-Abstract 2175.

•Sayeram S. Evaluation of 4D reconstruction methods for gated cardiac SPECT imaging in obese patients. Doctoral dissertation, University of North Carolina, Chapel Hill, NC, May 2009.

•Sayeram S, and J Izatt. High-resolution SDOCT Imaging – cutting-edge technology for clinical and research applications. 2008; Photonik International.

•Sayeram S, and J Izatt. Hochauflösende SDOCT – aktuelle Technik für Forschung und Klinik. 2008; Photonik

•Sayeram S, and DS Lalush. Performance Evaluation of 4D Reconstruction Methods for Gated Cardiac Single Photon Emission Computed Tomography in Obese Patients. 2007; Computers in Cardiology.

Contact this candidate