Clinical Experience

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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.
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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:
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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
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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
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