Medical Clinical

CURRICULUM VITAE

*) Name : Dr. SRIDHAR S.B.

2) Employment No. : 812

3) Date of Birth : 14/10/1974

4) Date of joining : 01/03/2010

5) Educational Qualification

(Mention the Name of the

College and University)

a) M.B.B.S., - SSMC, Bangalore University.

b) MD (Pharmacology) – KMC, Manipal Academy of Higher Education.

c) PCPV ((Professional Certificate in Pharmacovigilance) - by Catalyst Clinical

Services, New Delhi.

6) Registration Number : Karnataka Medical Council No. 52372

(Mention Medical Council/

Nursing Council/Pharmacy

Council/Dental Council/Others)

7) Experience (in Lotus)

a) Present Position : DGM- Clinical ( Nov 2014 - till date)

b) Functional role assigned : Head bio-studies ( Nov 2014 - till date)

c) Position Held Previously : Center-Head – Lotus House clinical facility

(Mar 2010 to Oct 2014)

8) Past Experience :

a) Employer : Lambda Therapeutic Research Ltd., Chennai

Designation: Manager

Duration: June 2007 to Feb 2010

b) Employer: Fortis Clinical Research Ltd., Faridabad

Designation: Senior Clinical Investigator

Duration: Feb 2006 to May 2007

c) Employer : Lotus Labs Pvt Ltd., Chennai

Designation: Clinical Investigator

Duration: Dec 2004 to Jan 2006

d) Employer: Vydehi Institute of Medical Sciences, Bangalore

Designation: Asst. Professor

Duration : Oct 2002 to Nov 2004

e) Employer

Designation: Medical practitioner (General Practice),Bangalore

Duration: Oct 2002 to Nov 2004

9) Membership in : Karnataka Medical Council

Professional Bodies

10) Papers Published / Presented :

Braz J Med Biol Res. 2005 Mar; 38(3):463-8.

Preclinical evaluation of the antidiabetic effect of Eugenia jambolana seed powder in streptozotocin-diabetic rats.

Sridhar SB1, Sheetal UD, Pai MR, Shastri MS.

11) Languages known : Read - English, Kannada

Write - English, Kannada

Speak - English, Kannada

12) Training programmes attended :

(Internal & External)

a)BLS and ACLS training at St. John’s Medical College, Bangalore.

b)Research and Methodology – KMC, Mangalore & KMC, Manipal

c)GCP Seminar and Workshop, Conducted by Dr.Arun Bhatt, Bangalore

d)Had participated in the workshop “Clinical Trials – A Global Opportunity” conducted by The Institute of Bioinformatics and Applied Biotechnology, Bangalore.

e)Had participated in the workshop “The Magic of Teams” conducted by Empowered learning systems, Pune.

Signature :

Date :

JOB RESPONSIBILITY

Head Bio-studies

1)Review overall functioning of all the Clinical facilities of Lotus to ensure GCP compliance and overall responsibility for the functioning of Clinical Department.

2)Determine feasibility to conduct Clinical studies along with the Medical Advisor and Managing Director.

3)Planning schedule of studies with Business Development / Project Management Group, Centre Head, Chief clinical services and planning of study conduct with Investigators.

4)Review of protocols for scientific soundness and for regulatory and SOP compliance.

5)Identify resources required for the smooth functioning of the Clinical department including infrastructure, manpower and systems and ensure that these are in compliance with regulatory requirements.

6)Ensure that all personnel in the Clinical department are trained in GCP, relevant SOPs and relevant Job specific procedures.

7)Ensure the development of working procedures, infrastructure and training of personnel to handle medical emergencies and manage trial related adverse events.

8)Review of AEs and SAE’s with Investigators and Medical Advisor.

9)Participate in clinical data review meetings at the completion of each study.

10)Facilitate resolution of client and regulatory queries and client audits.

11)Review overall functioning of all the Clinical facilities of Lotus to ensure GCP compliance and overall responsibility for the functioning of Clinical Department.

12)Determine feasibility to conduct Clinical studies along with the Medical Advisor and Managing Director.

13)Planning schedule of studies with Business Development / Project Management Group, Centre Head and planning of study conduct with Investigators.

14)Review of protocols for scientific soundness and for regulatory and SOP

compliance.

15)Identify resources required for the smooth functioning of the Clinical department including infrastructure, manpower and systems and ensure that these are in compliance with regulatory requirements.

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16)Ensure that all personnel in the Clinical department are trained in GCP, relevant SOPs and relevant Job specific procedures.

17)Ensure the development of working procedures, infrastructure and training of personnel to handle medical emergencies and manage trial related adverse events.

18)Review of AEs and SAE’s with Investigators and Medical Advisor.

19)Participate in clinical data review meetings at the completion of each study.

20)Facilitate resolution of client and regulatory queries and client audits.

21)Follow up of revision of SOPs with relevant personnel.

22)Timely review and resolution of non-compliance reports with relevant personnel.

23)Convene meetings with Centre Head and Quality Assurance department and other departments as and when required.

24)Responsible for Medical writing – protocol team for administration and scientific

activities.

25)To serve as Principal Investigator for studies as and when required.

26)Report to Chief clinical services on all activities.

27)To carry out any other responsibility as and when assigned by the management.

Note; In the absence of the Head Bio-studies, these responsibilities will be delegated to personnel identified by the management.

Name and Signature of the employee Name and Signature of the HOD

Date: Date:

Department: Department:

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