SONJAYY GUPTAA Ajmer, 305004, Rajasthan, India +91 982 8572928 sonjayyguptaa@gmail.com CLINICAL RESEARCH/ MEDICAL & HEALTHCARE SERVICES Seeking a challenging position across the industry which would give me the opportunity to utilize my skills for development of professional / personal goals & organizational objectives PROFILE Adroit, competent & diligent Professional with experience of over 20 years in the areas of Hospital & Healthcare Administration, Clinical Research, Clinical Trial Procedures, Standard Operating Procedures (SOPs), Protocol, Good Clinical Practice (GCP), Medical & Claims Investigation, Third Party Administration, Patient Recruitment Strategies, Medical Reviewer, Health Care Analysis and other relevant regulatory requirements. Well versed in clinical data building, conducting clinical trials, designing data management plan, data updating and review, in-house clinical monitoring and preparing structured project report with due inferences. Excellent liaising & networking skills with leading physicians and various patients. Strong analytical and communication skills, resourceful with the ability to mingle with people easily and manage things amicably Functional Competencies Expertise in carrying out clinical research on new & existing chemical entities and formulations used for treatment Diabetes Mellitus Type 2 Skilled in serving as emergency & critical cases expert for foreign patients by conducting rescue and repatriation operations, Ambulance transfer, Hospital treatment, Billing, payments etc ; successfully treated over 1000 foreign patients till date Functioning as an Expert Medical Coordinator & Mediclaim Investigator to Health Insurance Companies and investigating critical cases of claims as well as checking its authenticity. Guiding the processes of Clinical research, Site management ,Research Staff and patient recruitment, Ethics Committee formation, member selection, scheduled meetings, project submission, approvals etc.SAE, AE’s, Drug safety reporting and related communication with concerned authorities. Awarded in clinical research for best patient recruitment (Invited for Dr. Falk Pharma Symposium held in Mainz, Germany) CAREER GLIMPSE PAREXEL INTERNATIONAL CLINICAL RESEARCH ORGANIZATION Jan’10 – Jun’12 Clinical Research Physician Responsible for the Identification of potential investigators/Sites and ongoing review/ development, Identification of potential independent review board and ongoing review/development and for conducting ICH GCP,ICMR/DCGI guidelines, study specific training on regular basis at the sites. Responsible for assisting in the setup of patient and investigator information within the Clinical and Integic systems. Involved in Writing and updating the data management plan and other key trial documents. Administrated clinical data management process for multiple, simple or complex trials & projects to their successful conclusion. Ran ancillary programs (diagnostics, special listings, and reconciliation discrepancy listings) used to support the review of clinical trial data. Identifies tools and methods to improve or facilitate manual review process. Maintained full accountability and reconciliation of Clinical Trial Materials. Responsible for entire documentation related to regulatory procedures, archiving them at the end of the trials. Administered & provided protocol and related study training to assigned site team and establishes regular lines of communication with sites to manage ongoing project expectations and issues. Strived towards retaining patients by offering them best in class services Streamlined the consent process( Verbal and Documented) Verified the patient diary cards and ensuring updating of patient records in an optimum manner. Accountable for collecting & analysing lab samples Supervised the drug safety & web based reporting Handed data collection for crucial projects. Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting resolving monitoring / audit visit reports and other required study documentation. SCIO HEALTH ANALYTICS Dec’13 – Feb’14 Physician Reviewer of U.S patient hospital health records review & analytics for U.S biggest health insurer-“HUMANA” Trained by eminent American Doctors and Registered Nurses on. U.S Patients hospital records. Trained on reading, summarising, analysis and interpretation of U.S patient’s records. Trained on Millimen guidelines, interpretation and final conclusion of records. Interrelated and analysed 850 U.S hospital records with 95% accuracy. P.R HOSPITAL & RESEARCH CANTER, AJMER since Jan’00 Administrator & Clinical Research Physician Major Projects Insight Study - D.M type 2, Client - Norwich Clinical Research Pvt. Ltd. Profuse Watery Diarrhoea in Adults, Client - Glenmark Clinical Research Pvt Ltd Infectious/ Traveller’s Diarrhoea in Foreign Travellers, Client - Parexel Clinical Research Pvt. Ltd. Protocol No: RIT/AID; Participated in global clinical trial Phase 3 on foreign travellers diarrhoea conducted by multinational CRO - PAREXEL International Clinical Research Pvt. Ltd, Bangalore. Invited by sponsor Dr. Falk Pharma Gmbh, Germany and attended Symposia on Diseases & treatment in Gastroenterology in Mainz, Germany (October 2012) Protocol No: C003 ; Involved in Phase 3 clinical trial of profuse watery diarrhoea in adults conducted by CRO- GLENMARK Clinical Research Pvt. Ltd., Mumbai Protocol No: NIS-CIN-XXX-2011/3; Contributed in clinical trial and safety survey of existing chemical formulations & drugs used in treating Diabetes Mellitus Type 2 INSIGHT study conducted by CRO-NORWICH Clinical Research Pvt. Ltd, Bangalore STAR HEALTH & ALLIED INSURANCE COMPANY LTD., INDIA BAJAJ ALLIANZ HEALTH INSURANCE COMPANY LTD, INDIA since Jul’09 since May’07 Panel Medical Officer, Pre-Policy Health Check-up Medi Claim Investigator, Field visit reporter & Fraud Management Planning, organizing and directing the professional medical services program, consisting of all primary and specialty services for in-patient, out-patient, preventive and wellness programs Handling patients with physical examination, undertaking routine & diagnostic investigations. Ensuring administration of appropriate drugs to patients and handling patient counselling sessions. Counselling patients and attendants about the clinical condition, plan of management and progress of the patients periodically and as required Overall in charge of the Policy servicing section- all related servicing aspects including underwriting for revival of policies, assignments, settlement of claims customer services etc. Ensuring facilitated adherence to statutory compliances, policies and procedures as per the company’s norms and statutory provisions. Initiating cases on field for investigation of claims and following up with the claim coordinators regarding case details Communicating with doctors/hospitals for providing documentary proofs for accessing genuinity of claims Conducting Analysis of consolidated claims summary in various aspects viz. cashless, reimbursement, ailment, age band, amount band. MEDICAL & HEALTHCARE SERVICES Functioning as General Practitioner, Family Physician, Healthcare services provider, Medical administrator of Primary healthcare centre. Served as 24/7 Medical services provider to multiple overseas travel, health insurance companies, medical assistance companies and Third party Administrators abroad & India HEALTH INSURANCE & THIRD PARTY ADMINISTRATOR / INTERNATIONAL INSURANCE - FOREIGN PATIENTS since Dec’99 Offered 24/7 International medical provider services to various multinational overseas travel, health insurance companies & medical assistance companies Serving as 24/7 Emergency Medical Assistance Provider ( rescue & repatriation) expert for Indian / Overseas medical assistance companies & Third party administrators. Dealing with International patient emergency & elective specialty hospital treatment and International patient outdoor medical services in various network hospitals in India Insurance claim fraud investigation, Patient and Hospital record verification, Field visit report preparation. PHARMACEUTICALS & CLINICAL RESEARCH since Dec’99 since Dec’09 Dealing with local and central regulatory bodies Participating in study, documentation and Drug safety reporting, etc. Looking after maintenance of research site and its personnel’s recruitment as well as their functioning Managing Electronic Data Capture and handling filling & IVRS of new pharmacological Investigational products Heading selection of members for Ethics Committee, organising periodic meetings and looking after project submission & approvals Assisting in Phase 3 clinical trials conducted and audited by multinational CRO Awarded, Invited & Attended Dr. Falk Pharma, Germany Gmbh Symposium on Diseases in Gastro Enter logy & Treatment held in Mainz, Germany in September 2012 ACADEMIA MBA/PGDM (Hospital & Healthcare Management), 2005, Indian Institute of Health Management and Research, IGNOU New Delhi MBBS (Medicine), 1993, J.S.S. Medical College, Mysore, Karnataka, University, India Certifications Family Planning ICH-GCP HIPPA IT Skills - Computer software- Electronic Data Capture, MS Office & Internet Applications Date of Birth: 14th July, 1967 References: Available on Request