Mrs. Savitha Ganesh
Email:-, Mobile No. : -,-
Address: Sri Guru Nivasa,House No 3-61/2, Thenkabettu Post, K G Road, Mayadi,Udupi Taluk and
district. KARNATAKA.-576105
SUMMARY-
Serving as Clinical Assistant in KMC Manipal (Pediatrics Dept) from Aug -2019
to Mar-2020.
Served as Clinical Data Associate in Udison Infoware Pvt.Ltd,Udupi from December -2014
to Dec 2018.
Served as Clinical Research Coordinator in Kasturba Medical College Hospital
(KMC), Attavar,Mangalore from Jan 2012 to November -2014.
Served as Clinical Research Coordinator in Nanjappa Hospital, Shivamogga from Oct 2008
to 04th Oct 2011.
Served as Quality assurance officer in Neo Foods Pvt. Ltd., Tumkur from August- 2007 to
June-2008.
Passed M.Sc in Biochemistry and B.Sc in Microbiology, Biochemistry & Botany–science.
Passed PGDQMHHO from Symbiosis centre of Health Care, Pune in the year May 2018.
OBJECTIVES
To obtain responsible and challenging position where my education and work experience
will have valuable application.
EXPERTISED
1
Have good hold on MS- World, MS- Excel, MS- Power point , PDF & also Internet.
PROFESSIONAL EXPERIENCE
Served as Quality Analyst in Neo Foods Private Ltd, Tumkur from Aug 2007 to Jun 2008.
Served as Clinical Research Co-Ordinator in Nanjappa Hospital, Department of Cardiology,
Number 660, Kuvempu Road, and Shivamogga-577201.Reported from 17th Oct 2008 to till
date.
Served as Research Coordinator in KMC Hospital, MCCR Department, Attavar, Mangalore
from Jan 2012 to till date.
Presently working as Clinical Data Associate in Udison Infoware Pvt.Ltd,Udupi from
December -2014 to till date
Job description as CRC:
1 Preparation and subsequent submission of study related documents to the Ethics
committee for approval.
2 Experience in counselling and recruitment of patients.
3 Coordinating between the site and sponsor/CRO and all activities related to the study
within the site.
4 Ensuring that study is going as per ICH & GCP guidelines and also the study protocol, SOP
and other regulatory requirements.
5 Maintenance of trial master files (patient screening log, patient enrolment log, drug
accountability log, etc.).
6 Filing the case report form [CRF/e-CRF] by using source document and query Management.
7 Randomization of patients (through IVRS/IWRS).
8 Reporting the SAE to ethical committee and the sponsor.
9 Filling sample requisition forms of the patient.
10 Shipping of samples to International and Local labs.
11 Experience in performing psychiatry tests.(MCCB -Measure cognition in individuals
diagnosed with schizophrenia and related disorders)
Job Description as Clinical Data Associate:-.
10.
11.
12.
Have hands on experience in medidata rave and clinical inform .
Have an experience in clinfoware systems.
Manage Data entry activities.
Be able to follow and get proficiency on related regulations,CDISC,CDASH,ICH,GCP,HIPPA,21
CRF Part 11 compliance and Good Clinical DM Practice.
Generate SOPs related to Data Management
Provide assistance to Project Manager in study start up, closure, data entry, query
management, AE/SAE reconciliation, Edit checks in place, Database set up.
Quality control review of all study documents, compliance with monthly training, report
timelines.
Guiding the developers for implementing the requirements as per Client needs.
Creating CR for Client and Site people raising quires and new requirements. Guiding the
developers to fixing the issues as per DM Team and Client CRs. Creating Post-Production CR
for Client and for the queries raised by site CRC.
Supporting Team for User related issue resolution.
Preparing and managing all Data Management related documents.
Medical Dictionary Coding for Adverse Events, Prior and Concomitant Medications, and
Medical History Verbatim Terms.
13. Generating reports and system validation.
GOOD CLINICAL PRACTICE & PROTOCOL TRAINING
Attended the Investigator’s Meeting/ Seminar as Research Coordinator:
1
2
3
4
5
At Bangalore, study Coordinators Meeting” from 29th Oct 2009 to 01 Nov 2009.
At Beijing China. , Investigator Meeting on 15th June 2010.
At Goa, by Bristol Meyrs Squib on 4th Sep 2010.
At New Delhi, by Eli Lilly and Company on 10th Mar 2011.
At New Delhi, by Searchlyte on 28th Nov 2012.
QUALIFICATION
Post Graduate Diploma in “Quality Management of Hospital & Healthcare Organization”
(PGDQMHHO) from Symbiosis centre of Health Care, Pune in the year May 2018
M. Sc (BIOCHEMISTRY)
June 2007 (Regular),
Distinction (78. 61% , 7th Rank)
DOS in Biochemistry
Kuvempu University
Shivagangotri, Tholahunase
DAVANAGERE-577 002
B. Sc (MICROBIOLOGY, BIOCHEMISTRY & Botony)
May 2005 (Regular),
First class, (71.0%)
Sahyadri Science College.
SHIMOGA.
Clinical Trials PROJECTS
1) A Phase 2, Double-blind, Randomized, Placebo-controlled clinical trial in patients with. Acute
Coronary Syndromes.
2) A Phase 3, Double-blind, Randomized, Placebo-controlled clinical trial in patients with Atrial
Fibrillation.
3) A Phase 3,Double-blind, Randomized, Placebo-controlled clinical trail in patients with Unstable
Angina / Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) Acute Coronary
Syndrome (ACS) who are Medically Managed.
4) A Phase 3, Double-blind, Randomized, Placebo-controlled clinical trial in patients with recent
Acute Coronary Syndromes.
5) A pilot , multicentre, randomized, open label, controlled trail with patients presenting with AMI
with ST-segment elevation or new left bundle branch block (LBBB).
6) A phase3 simple multicentre, international randomized placebo-controlled trail with major
vascular events.
7) A Phase 2 Randomized, Double Blind, Placebo Controlled Multicentre and Parallel Group Study of
the Safety, Tolerability and Efficacy of YM150 in combination with Standard Treatment in
Secondary Prevention of Ischemic Vascular Events in Subjects with Acute Coronary Syndrome.
8) A randomized double-blind 2x2 factorial controlled trail of the efficacy and safety of low strength
Polycap versus two doses of low strength Polycap and of low strength potassium
supplementation in patients with stable cardio-vascular disease or ischemic heart disease.
9) “Prospective, multi-centric, open label, two arm, parallel group, active control, randomized,
comparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera® in patients
with Follicular B-Cell Non-Hodgkin's Lymphoma”.
10) A Study of RO- in Patients With Persistent, Predominant Negative Symptoms of
Schizophrenia (NN-) A Study of RO- in Patients With Sub-optimally Controlled Symptoms of
Schizophrenia (NN-) Ministry of Health and Family Welfare, Government of India initiated study titled
“A Multi-centre Active AEFI Sentinel Surveillance (MAASS)” with support of
International Clinical Epidemiology Network (INCLEN) Trust International, New
Delhi.
ACHIEVEMENTS
Attending seminars & workshops.
Organization & active participation in health camps.
I have faced a sponsor audit as well as monitoring visits.
4 Active participations in personality development programs.
FELLOWSHIP PROGAMME
Participated in IISc Summer Fellowship Programme conducted during the period of 5th June
to July 2008, carried out mini project entitled: ‘Essential Biochemical Techniques of DNA
and Protein chemistry’ under guidance of Prof. D N Rao, Dept. of Biochemistry at IISc.
Techniques handled such as pH meter handling, DNA isolation, electrophoresis and gel
elution, blotting techniques such as Southern and Western blotting, ELISA, PCR etc.,
SOFT SKILLS
1
2
3
4
Presentation and Public Speaking.
Training & Facilitation.
Documentation.
Event planning and coordination.
PERSONAL SKILLS
1.
2.
3.
4.
Positive Attitude, Determined, High Energies.
Hard Working, and Sincere.
Good decision making and analytical skills.
Able to handle people in a very efficient way.
PERSONAL PROFILE
Name
Husband Name
Birth Place
DOB
Marital Status
Languages Known
: Savitha Ganesh
: Ganesh V.N
: Udupi
:-
: Married
: Kannada, English & Hindi
DECLARATION
I hereby declare that the above information furnished is true to the best of my knowledge and
belief.
Place : Udupi
Date
: 26 Dec 2020
Savitha Ganesh
