New York City Metropolitan Area
Dr. Monica Gaidhane is a distinguished Physician-Scientist and Epidemiologist, currently serving as Strategy Lead for Clinical Research & Medical Affairs, and Director of the Clinical Research Center. She has 17 years of experience in disease surveillance, clinical trials, biostatistics, database management, and specialized healthcare delivery. Dr. Gaidhane holds a Web of Science H-Index of 48 & is the co-founder of two nonprofit healthcare organizations dedicated to credentialing, research, training, & enhancing healthcare outcomes, underpinned by 8 years of lead evaluator & C-suite leadership experience. She presently oversees multi-site studies and drug/device trials, has completed over 34 clinical research studies, authored 120 publications, presented 175 clinical research abstracts, received seven awards, and directed more than 50 accredited medical education conferences & scientific congresses, featuring integrated CME and industry partnership strategies across Gastroenterology, Therapeutic and Interventional Advanced Endoscopy. She has co-founded 2 nonprofit organizations that offer healthcare education such as CME medical conferences in-person and live online webinars, online education series, didactic presentations, research, consulting, RCM, grant life cycle management, mentorship, voluntering opportunities and networking to Physicians. Skills and Specialties: Internal Medicine, Chronic Diseases, Obesity Epidemiology & Research, Clinical Research, Clinical Trials, Pancreatico-Biliary research, Pulmonology, Infectious diseases epidemiology, Cardiology, Oncology, Endocrinology, Social and Behvioural health, Research Journal editor, Peer reviewer, Non-profit trustee, marketing, grants submission. Cinical Trial platforms for devices/drugs and wearables. Digital solutions for multi-site clinical trials. Artifical Intelligence (AI) for healthcare integration; key evaluator for clinical trial digital solutions. Evaluation & Ux include: SAS, JMP, Qualtrics, QBOnline, Microsoft 365 + co-pilot, SPSS, Provation, Medcalc, STATA, OnCore, R, RedCAP, EPIC, Adobe Acrobat, Photoshop, InDesign, Medidata, IQVIA, ADVARRA, WCG, CRIO, CLINICAL.LY, VEEVA Vault, FLORENCE, Biorce, Deep 6 AI, Cloudbyz, Medrio, SAP, Salesforce, Zoho & many more. -Pubmed: https://www.ncbi.nlm.nih.gov/pubmed/?term=gaidhane+m - Web of Science: https://www.webofscience.com/wos/author/record/B-9414-2009 -ORCID ID: https://orcid.org/0000-0001-6773-7080- Scopus ID: https://www.scopus.com/authid/detail.uri?authorId=53463587000- Researcher ID: https://www.researcherid.com/rid/B-9414-2009
I actively contribute to advancing gastrointestinal endoscopy through my role on the Editorial Review Board. • Conduct peer reviews to ensure the scientific integrity and clinical relevance of manuscripts. • Focus on pioneering interventions, including EUS-guided procedures and AI integration in diagnostics. • Collaborate with an international team to guide the journal's publication trajectory and uphold ethical research standards. - Core Collection Index: Emerging Sources Citation Index (ESCI) under the Gastroenterology & Hepatology category. Journal Impact Factor (JIF): 1.2; Scopus CiteScore: 3.4; SCImago Journal Rank (SJR): 0.521
Director, Physician, Medical Affairs/Strategy/Operation Admin. AI Strategy, Implementation & Innovation •Multi-Site Clinical Development Strategy (Drugs, Devices, Wearables) •Phase I through IV Clinical trials, End-to-End Clinical Trial Strategy •Clinical Study Design & Protocol Creation and Optimization •Various diagnostics, including lab and imaging •Digital Centralized and Decentralized Clinical Trials Management •Recruitment Strategic Planning & Execution •Cross- Functional Team Management & Research Mentorship •Medical Affairs & Ethical Research Policy Specialist •Clinical Trial Sponsor, Contract Research Organization & Site Management Organization Relationship Management •Contract, Agreement, NDA & COI Lifecycle Management •Therapeutic Expertise: Internal Medicine, Gastroenterology, Cardiology, Obesity, Oncology, Chronic Diseases, Infectious Diseases, Genetic Therapy •Advanced Endoscopy & Pancreatico-Biliary Research •Clinical Epidemiology & Outcomes Research •AER, Sanitization etc. •Advanced Clinical Trial Biostatistics, Predictive Modeling & Regulatory •Skilled in analyzing Randomized Controlled Trials (RCT) data and Real-World Data (RWD) to produce clinical insights •Budget Development & Financial Controls •Grant Strategy, Submission & Lifecycle Management •Capital Allocation & Resource Optimization for Clinical Research •Medical Conference Revenue Strategy: Sponsorship Acquisition,Industry Partnerships & Exhibit Monetization •Evaluation & Deployment of Al in Clinical Research & Diagnostics •Al for Diagnostics & Data-Driven Healthcare Delivery •Clinical Trial platforms & Digital Solutions Assessment •Data Governance, Online security & Clinical Data Integrity •Medical Writing, Scientific Communications & Peer Reviewer •CME Strategy, Learning Management System(LMS) Architecture & Global Medical Education Management •Press Releases & Social Media Content for Marketing and Awareness - Procurement of various hospital based supplies- Medical Admin Role
Co-Founder, Vice Chair of the Board of Trustees, Leadership Board, Chief Financial Officer and Interim Chief Technology Officer and Interim Chief Marketing Officer, Director of Research. Key decision maker, Key opinion Leader, Project Management, Grant Submissions, Fundraising, Recruitment of consultants staff and volunteers. Research Initiatives and adopting GEN AI for Research. As a Co-Found and vice chair of the board of trustees, I am a key decision-maker at the Foundation for Interventional & Therapeutic Endoscopy. I played a pivotal role in shaping the organization’s financial strategy, medical research and operational framework, IT/TECH/AI integration and lead marketing campaigns. My responsibilities included overseeing budgeting, financial accounting, event management, project management, leading fundraising efforts, marketing campaigns, awarding grants and recruiting top talent contractors and volunteers to support our mission. Through these initiatives, we have successfully secured substantial funding and built a robust team dedicated to advancing therapeutic endoscopy in every way.
• Co-founded Innovative Digestive Health Education & Research Inc, driving strategic direction as COO and Interim CFO , CIO & CMO • Spearheaded grant submissions & fundraising initiatives, securing over $500,000 in funding for innovative national and international contiuing medical education programs for advanced endoscopists for past 15 years • Oversaw the development of educational programs, enhancing community awareness & engagement in digestive health as Executive Director of Research and Education. - Offers New Jersey specific and Federal physicians and other healthcare professional credentialing consulting process for new employees - My responsibilities also include event management, & recruiting top talent contractors & volunteers to support our mission. RESPONSIBILITIES AND EXPERIENCE: Research and Development (R&D) all phases· Clinical Trials All phases· Investor Relations · Operations Management · Finance · Executive Leadership · Key Opinion Leaders · Grant Administration · Key Decision Maker · Media Relations · Interdepartmental Liaison · International Liaison · Fundraising · Project Management · Project Planning · Project Commissioning · Project Delivery · Project Coordination · IT Strategy · Reporting & Analysis · Event Management · Medical Education · Educational Leadership · Protocol Review · Financial Oversight · Project Oversight · Budget Oversight · Staff Oversight · Web Development · Search Engine Optimization (SEO) · Medical Writing · Scientific Review · Scientific Data Management · Scientific Communications · Clinical Research · Clinical Trial Analysis · Clinical Data Management · Clinical Study Design · Trial Management · Medical Research · Medical Devices · Strategic Consulting · Consultant Coordination * online security measures, cybersecurity incident response consulting , Artificial Intelligence Tools for Research Evaluation, SFOs and CROs and clinical trial software/digital solutions evaluation, Recruitment of contractors and volunteers.
Chief Operating Officer