CURRICULUM VITAE Students Name: Dr. Mahira. M. Saiyed Basic Qualification: Bachelors of Homoeopathic Medical College & Surgery Professional Qualification: Post Graduate diploma in Clinical Research and Pharmacovigilance Reg No: G-15458 E-mail :mahirasaiyed@yahoo.co.in Mobile +91–9998393400 Home 07926580044 Present Address: 22,Park Lane , near GPCC office, Kochrab ,Paldi Ahmedabad 06 Career Objective: An energetic aspirant looking for an entry level position to make an Identity by learning and experiencing all that comes across in the day to day life by giving the most dedicated efforts Clinical research knowledge: Clinical research: Phases of CR, Ethics committee and IRB ICH GCP, Indian GCP, ICMR, Schedule Y Drug discovery and development Sponsor, Investigator, Vendor responsibilities IND, NDA, Informed consent process, subject selection Site selection, initiation, close out, contract, budget Protocol design, SOPs, CSR, CRF design, review and SDV Site monitoring, Audit, Inspection Pharmacovigilance: Expedited reporting requirements Signal detection, PV database Regulatory aspects of PV, QA in PV ICSR case processing, Risk management, Medical evaluation of AEs PSUR, MedDRA, Narrative writing Clinical data management: Biostatistics, Data analysis and reporting Professional Qualification: Personal Data Date of Birth : 19/11/1988 Sex : Female Nationality : Indian Marital Status: Married Languages Known: English, Hindi & Gujarati Academic Credentials Aggregate PGDCRPV(Post Graduate Diploma in Clinical Cliniminds, Delhi Research and Pharmacovigilance) Basic Qualification Permanent Address: 22,Park Lane , near GPCC office, Kochrab ,Paldi Ahmedabad o6 University Completed Bachelors of Homoeopathic Medical College & Surgery Completed JOB PROFILE: 1. Serving as a doctor for an interdisciplinary healthcare team. 2. Taking medical History of the patients, physical examination, vital signs for OPD patients. 3. Performing various diagnostic tests- ECG, TMT, Vibrotherm test, Biothesiometry, Central Arterial Pressure, etc 4. Educating the patients for the using devices like insulin syringes, insulin pens, glucometers, insulin pumps, Continuous Glucose Monitoring device, etc. 5. Educating and counseling the patients regarding Diabetes and its complications and its Prevention. 6. Advising the patients the importance of Self Monitoring of blood Glucose (SMBG), and teaching them to treat acute complications of Diabetes. 7. Educating patients to prevent hyper-hypoglycemic events. 8. Counseling for lifestyle modification and Healthy diet and regular exercise. 9. Treating of patients with Diabetic ketoacidosis on OPD –IPD basis. 10. Working as a project coordinator for type 1 Diabetes Programs like CDIC and LIFE FOR A CHILD 11. Attending to minor procedures relating to Diabetic Foot complications namely dressing and debridement of the wound. 12. Working as Clinical Research Coordinator for the ongoing Trials at the site. Clinical Experience Diacare - Diabetes and Hormone Clinic Started career as a MEDICAL OFFICER under Dr. Banshi Saboo, Diabetologist and Endocrinologist at Diacare – Diabetes and Hormone Clinic, a centre of excellence recognized by Indian academy of Diabetes at Ahmedabad, Gujarat/ India in May 2013. Promoted to PROJECT COORDINATOR FOR TYPE 1 DIABETES at Diacare – Diabetes and Hormone Clinic, a centre of excellence recognized by Indian Academy of Diabetes at Ahmedabad, Gujarat/ India in November 2012Ongoing for type 1 Diabetes in children in CDIC- Changing Diabetes In Children, program and Life For A Child Program since 2012. W ORKED AS A COORDINATOR FOR CHANGING D IABETES IN CHILDREN (CD IC) P ROJECT SUPPORTED BY ISPAD AT DIA CARE CENTRE, AHMEDABAD (INDIA). W ORKED AS A COORDINATOR FOR LIFE FOR A CHILD (LFAC) PROJECT SUPPORTED BY IDF AT DIA CARE CENTRE , AHMEDABAD (I NDIA). Prompted to CLINICAL RESEARCH COORDINATORATDIACARE-DIABETES AND HORMONE CLINIC AND ALSOWORKING AS A PROJECT COORDINATOR AT DR. JIVRAJ MEHTA SMARAK HEALTH FOUNDATION AND BAKERI MEDICAL RESEARCH CENTER SINCE 2014 Research Experience: Experienced with ICH-GCP Guidelines since last 3 years Currently working with different Clinical Trial for Type I and II Diabetic Patients and other metabolic Disorder Working as a CLINICAL RESEARCH COORDINATOR Participation in Startup Investigator meets Communication with Ethics committee and Sponsor Selection of Eligible Subjects Delegate to various subject engagement program Educate subject medically in every visit according to protocol Evaluation of Inclusion/Exclusion criteria Informed consent process Subject Randomization through IVRS & IWRS Practical Trial Coordination CRF completion-Paper & E-CRF Subject Follow Up & retention Device Training to Subjects i.e. Glucometer, Injecting Device Drug Accountability Maintenance of Investigator File Adverse Event Evaluation & Reporting of SAEs Facing Interim Monitoring Visit Ensuring the Study is conducted in Compliance with Schedule Y, ICH-GCP & Sponsors Standard working Procedure under Supervision of Principal Investigator Attending Investigator Meeting CLINICAL TRIALS Efficacy and Safety of Liraglutide versua Sulphoylurea both in combination with metformin during Ramdan in Subject with Type II Diabetes, in 2014 Study of Canagliflozin on Cardiovascular outcome in adult subjects with Type II DM (CANVAS TRIAL) Ongoing A trial comparing Cardiovascular Safety of Insulin Deguldec verses insulin Glargine in Subjects with Type II diabetes at high risk of Cardiovascular events, in 2014 ongoing A Phase II multicentre Randomized Parallel group Double Blinded and Control group Clinical Trial to ascess the Effectiveness of Chronic Diabetic Foot Ulcer,in 2015 CONFERENCES AND ACTIVITIES: MANAGEMENT OF TYPE 1 DIABETES IN CHILDREN ORGANIZED BY NOVONORDISK EDUCATION FOUNDATION IN 2013, BANGALORE. AFRO-ASIAN CONCLAVE OF CHANGING DIABETES IN CHILDREN, DELHI 2014. 24TH ANNUAL CONFERENCE OF INDIAN SOCIETY OF HYPERTENSION, BPCON 2014, AHMEDABAD. 10TH ANNUAL NATIONAL OBESITY CONFERENCE, AAROCON 2014, JAIPUR. DIABETES INDIA 2015,CHENNAI,TAMIL NADU ORGANISED VARIOUS CAMPS FOR TYPE 1 AND TYPE 2 DM, HYPERTENSION, EDUCATION CAMPS FOR PATIENTS AT AHMEDABAD, BARODA, RAJKOT, JAMNAGAR, ANAND, ETC. ORGANIZED MANY TRAINING PROGRAMS FOR H EALTH EDUCATORS ALONG WITH WORLD DIABETES FOUNDATION AND INDIAN D IABETES RESEARCH FOUNDATION AT AHMEDABAD. TEHCNICAL PROFICIENCY: OPERATING SYSTEM: WINDOWS XP, WINDOWS 7, WINDOWS 8 MS OFFICE: WORD , EXCEL, POWER POINT, OUTLOOK INTERNET BROWSING I hereby declare that the information given above is genuine to the best of my knowledge & if you give an opportunity to work in your organization, I will put my best efforts. Place: Ahmedabad Dr Mahira Saiyed