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Clinical Research Experience:

Indication Phase Role Status Remark
Osteoarthritis
(Diclofenac sodium gel 1 %)		 III Principal Investigator Completed USFDA cleared
Osteoarthritis
(Diclofenac sodium gel 1 %)		 III Principal Investigator Completed NA
Vitamin B12 deficiency
(Methylcobalamin Nasal Spray)		 III Principal Investigator Completed NA
Designation: Clinical care director (Medical director)
Responsibilities:
  • To supervise and manage Clinical care operations in coordination with dept. head (i.e. Head, clinical services)
  • To support and promote auxiliary services like radiology, pathology, dentistry, physiotherapy and rehabilitation  in coordination with respective dept. head/consultant(s)
  • To guide Quality Assurance (QA) dept. to develop hospital policies/procedures and supervise their operations.
  • To facilitate development of medical (non-cardiac) departments in consultation with board of directors at CIMS
  • To prepare MoUs for tie up or collaboration with various external agencies for services related to patient care/management.
  • To manage site operations (SMO) for clinical trials
  • To participate various committee meetings as member/chairperson and supervise its functioning
  • To guide Human Resource (HR) dept. to develop various HR policies
  • To supervise and manage pharmacy operations in coordination with senior pharmacists and purchase dept.
  • To explore new opportunities or  value added services for CIMS and facilitate for implementation at CIMS
  • To guide and/or coordinate with other departments like hospitality/administration, communications, IT dept. etc for various inter departmental issues/ processes.
  • To assist finance department for various packages/charges for hospital services.
  • Member of medical executive committee
Organization: Veeda Clinical Research, Ahmedabad, India
Duration: Dec‘05 – Jan’10
Designation: Principal Scientist (Senior Manager)
Responsibilities:
  • SCIENTIFIC:
  • To ensure that all Clinical Pharmacology In-house Projects (clinical pharmacokinetic, pharmacodynamic and Phase I studies) are carried out as per GCP/GLP guidelines.
  • To serve as Principal Investigator for Phase I/II studies on NCEs, Experimental studies and Pharmacokinetic/Bio-equivalence studies on generic and NDDS products.
  • Provide medical support, input and information for the preparation of Protocols and Case Records Forms for clinical studies with NCEs and generic products.
  • Overall clinical/ safety supervision and management of Phase I/II Clinical Trials, Pharmacokinetic and Bio-equivalence Studies.
  • Creation and /or revision of SOPs as per the need and ensuring their implementation
  • To appoint clinical study coordinators for all the projects carried out at Clinical Pharmacology Unit.
  • Co-ordinate with QA dept. to handle regulatory audits for clinical studies
  • Protocol development in consultation with sponsors for Phase I or Phase II clinical trials (exposure in Metabolic, Neuropsychiatry and biotech area)
  • Administration of IRB related processes
  • MANAGERIAL:
  • Overall management of clinical study team operations and projects
  • Support business development activities and response to RFPs
  • Coordination of various activities with other departments (e.g. Lab, QA, Regulatory, Finance, HR etc.)
  • Awarded with ‘Innovation award’ at Veeda for year 2007-08
  • DSMB Member:
  • Designated as Co-Chair person for Phase I clinical trials for Vaccine and New Chemical Entities (NCE)

TRAINING:

Sr. No. Title Organized / Conducted by Place Year
01. Cardiology Update National Conference of
Indian College of
Interventional Cardiology		 Mumbai Feb. 2003
02. Training on ‘BLS and ACLS (ICU training)’ Sterling Hospital Ahmedabad Mar. 2006
03. Training on ‘ Managerial Effectiveness’ Veeda Clinical Research Ahmedabad Mar. 2006
04. GCP training Veeda Clinical Research Ahmedabad Jun 2006, 2007, 2018, 2019
05. GLP training Veeda Clinical Research Ahmedabad Apr. 2007
06. MUSE System user training GE Healthcare Ahmedabad May 2007
07. Powerful writing skills AMA Ahmedabad Sep. 2006
08. International Conference on ‘Contemporary issues and future challenges in drug development’. South Asian chapter of ACCP & Seth G S Medical college Mumbai Oct. 2007
09. Training programme on ‘Performance Management System’ GE Healthcare Ahmedabad May 2007
10. Seminar on ‘Global approaches to cardiac safety – 2008’ Quintiles Inc. Mumbai Mar 2008
11. Training programme on ‘In search of business excellence’. Veeda Clinical Research Ahmedabad Jul. 2008
12. Asia Pacific Clinical Trials Congress Indian Drug Manufactures’ Association (IDMA) Mumbai Nov 2008
13. International Conference on Biomedical and Genomic Research Human Genetics Centre (HGC), Gujarat University Ahmedabad Jan 2009
14. Training on Information Security systems Veeda Clinical Research Ahmedabad Feb 2009
15. Awareness Programme on NABH standards Quality Council of India Ahmedabad Oct 2009
16. Internal Counsellar Programme on NABH standards Quality Council of India Ahmedabad Jul 2010
17. Diploma in Polysomnography MediServe Sleep Institute (Sleep lab) Hyderabad Dec 2010
18. Cardiology Conferences CIMS Con – Cardilogy update ACC – Cardiology Update ACC Indian chapter Ahmedabad, Mumbai 2011 – 2019 2014
19. Diabetology Conference, Triology – Recent updates in diabetes and lipid disorders, TIMEs Con – Update in diabetes and renal disease APA Jaipur, Ahmedabad 2015
20. ISG Con National conference in GI and liver disease Indian Society of Gastroenterologist (ISG) Ahmedabad 2014, 2017, 2020
21. National Conference in liver and Biliary disease IAPSL Delhi 2015
22. 2D-Echo Fellowship CIMS Hospital Ahmedabad 2014
23. National conference in Critical care medicine ISCCM Ahmedabad 2014, 2018
24. RSSDI- Research Society for Study of Diabetes in India RSSDI Hyderabad 2016, 2020
25. National Conference in Endocrinology (ESI CON) ESI Trivendrum 2017, 2020
26. Cleveland Clinic Advanced Certificate Course in Diabetes CCACCD Delhi 2018

PRESENTATIONS GIVEN:

Sr.No. Title / Topic Organized / Conducted by Place Date
01. “Roles and Responsibilities of Investigator” Veeda clinical research Ahmedabad 18 Aug 2007
02. Electrocardiography (ECG) training for clinical team Veeda clinical research Ahmedabad NA
03. “Glucose clamp technique” Veeda clinical research Ahmedabad 20 Mar. 2007
04. “Roles and Responsibilities of Investigator” Veeda clinical research Goraj, Baroda 20 Jun 2008

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