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Title Clinical Research Development
Target Location US-GA-Alpharetta
Email Available with paid plan
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Email EMAIL AVAILABLE phone # PHONE NUMBER AVAILABLECore leadership Skills and ExpertiseMedical professional with over 30 years of experience leading the development and deliveryOf profitable health care throughout the US and India.Combines strong research and administrative expertise as a licencsed medical doctorKey Career Accomplishments10 years of academic Medicine, comprehensive transformation 80 bed hospitalResulting inhospital being ranked number on both clinically and financially within50 hospital system.Quality CareImproved80% of clinical qualitymeasures of 80 bed hospital and achieved topQuality scores.Completed several joint ventures between private health care organizationsResulting in subspeacialty carebeing provided in neighboring areas. 200XProfessional experienceSitapur Eye hospital 350 beds catering to the needs of one million people in the cityoSitapur Uttar Pradesh IndiaoObtained DOMS a diploma in Ophthalmology Medicine and Surgery. It is Board certified in India.It is recognized by the British Medical councilLearned many new surgical procedures from Visiting surgeons from EnglaObtained MD degree from Guntur Medical college Guntur Andhra Pradesh India.It is mentioned WHO directory.www.gmcana orgWorked at Grady Health System Endocrinology divison Atlanta GAoScreened patients with Eye Diseases after long duration of Diabetes.oBE a part of Clinical grand rounds of Emory University Ophthalmology division. IWorked as a Liasion between Endocrinology and Ophthalmology of Emory University.Referred patients who needed surgery and photo coagulation for retinal diseasesLearned lot new approaches in treatments for AMD ( age related macular disease)New drugs developed for glaucoma by reading ophthalmology Journals.EducationResearch ExperienceWorked along with my associate professor Dr Rekha Goel in a research project Moorens Ulcerand Subconjuctval dislocation of lens due to a bullgore injury.A paper published in Psychiatic Journal on Diabetes and Depression and how it affects Ocular complications in the long term at Grady Health System Atlanta Georgia. Strong scientific and academic background with deep understanding of retina and eye diseaseClinical research or pharmaceutical experience in ophthalmologyKnowledge of drug developmentGood networking ability in cross-cultural environmentStrong interpersonal, communication, presentation, and negotiation skills across all levels of the organizationAs a Clinical research Coordinator screened patients for drug studies,did follow upRecognized any sideaffects and warned the pharmaceutuical companies to withdrawAnd suspend the study.Teaching ExperienceEducated hospital staff on new drugs in the treatment of glaucoma.Delivered presentations to the rsidents and the faculty of morehouse school of medicine and Diabetes and ocular complications.Professional AffiliationsMember of AllIndia Ophthalmology AssociationObtained ECFMG certification in USA after passing USMLE examsCommunity ServiceOrganizationPerformed operations on Cataract, Glaucoma in the Eye camps conducted by Lions and Rotary clubs.Some projects were supported by OXFAM of England at Campbell hospitalCuddapha Andhra Pradesh IndiaOrganizationParticipated in free camps at the regional and state level giving vision with best surgical procedures. I have deep scientific, technical, and clinical expertise in ophthalmologyUnderstands and keeps updated with the pre-clinical, clinical pharmacology dataCritically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive productsBy attending seminars Ophthalmology associations keep up to dateKnowledge and developments in the clinical fieldLanguagesList the languages that you know, along with your level of proficiency. Use an appropriate proficiency scale such as the ACTFL which provides guidelines for Novice, Intermediate, Advanced, Superior, and Distinguished levels in Listening, Speaking, Reading, and Writing.Telugu Hindi and English proficient .Currently learning JapaneseOtherLove reading books,listen to music.CitizenshipMain responsibilities:Some of the Clinical Research Directors (CRD) core job responsibilities include those listed below, as well as all other duties assigned.Scientific and Technical Expertise:Has and maintains deep scientific, technical, and clinical expertise in ophthalmologyUnderstands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interestCritically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive productsMaintains visibility within the therapeutic area to maintain credibility with internal and external stakeholdersKey responsibilities:Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information availableLeads the clinical development including planned life cycle management (LCM)Ongoing assessment of the product benefitrisk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations teamImplements strategies to identify, monitor and resolve clinical program/trial issues.Serves as the Study Director and Medical Monitor for a study or clinical program as well as reviewing and monitoring study data.Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholdersPrepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).Provides clinical input to Statistical Analysis Plans, Target Product Profile and Risk Management PlanWrites/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigatorsReviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the projectLead the medical/clinical assessment of license-in opportunities, as neededManage other CRDs and clinical scientists in the same program, as neededThe CRD is representative for Clinical Development:at the Global Project Teamin meetings with Regulatory Agenciesin Steering Committees (SC) and Data Monitoring Committees (DMC)at the Benefit Risk Assessment Committeeat the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)Basic Qualifications:Medical Doctor (MD) Required, Ophthalmology SpecialistMore than 5 years of clinical or scientific experience, or more than 10 years industry experience within the field of ophthalmology and retinal diseasesFluent in English (verbal and written)Preferred Qualifications:Board certified or eligible in OphthalmologyCompletion of a fellowship program in one of the following subspecialties: medical retina/uveitis, vitreoretinal surgery, neuro-ophthalmologyStrong scientific and academic background with deep understanding of retina and eye diseaseClinical research or pharmaceutical experience in ophthalmologyKnowledge of drug developmentGood networking ability in cross-cultural environmentStrong interpersonal, communication, presentation, and negotiation skills across all levels of the organizationPerformance oriented with ability to work along agreed timelines and a focus on strategy and executionOutstanding communicator. Excellent problem-solving .conflict resolution and decision making skills.References

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