Management Developer
Resume:
Dr.M.DHINAKARAN
Working location: Hyderabad
B.P.T., M.I.A.P., I.G.P.T.., WorkinG Organization: NOVARTIS for Cognizant
Mobile: +91-730*******
Email: ***********@*****.***
Career Objective:
Seeking a challenging environment that encourages continues work and provides Exposure new ideas and stimulates personal and professional growth and also ensuring High standard of their work by taking care of quality, accuracy, Reliability, and credibility.
Area of interest: Clinical Trial Research/ Clinical Data Management.
Professional Qualification:
College studied : Sri Ramachandra Medical College& RI, Chennai.
Course finished : April 2001
Internship Done : 6 months in Sri RamaChandra Medical College, Chennai.
AWARDS & HONOURS:
Awarded ‘Quarterly Summit Champions trophy’ for our Team in best outcome for the Quarter (Jun-08 to Aug-08).
Recognized appreciations for ‘the commitment to developing people-08’ at Accenture.
SPOT AWARD (High permananence delivered) for best permanence in team got from the Deal.
SUMMIT AWARDS- (Numero uno award) for best permanence in business devolpelor, value creator and people developer for the month of Dec 08.
SUMMIT AWARDS- (Numero uno award) for best permanence in business devolpelor, value creator and people developer for the month of Mar 09.
SUMMIT AWARDS- (Numero uno award) for best permanence in business devolpelor, value creator and people developer for the month of July 10.
Specialization:
Have an overall experience of 5 years in Clinical Trial Management, and Diagnostic lab.
Experienced in Oracle Clinical, MedDRA, WHO & SnoMED (Dictionaries), Novartis-Autocoder, Coding glossary review, Data Entry Process & Corrections, pulling out CRF’s & Corrected Copies.
Know the process of Clinical Data Management, Clinical Trial Process, Client Interaction, Training SOPs, Time Allocation System, Database Lock & Unlock, TAO Studies, Discrepancy Status, Business Continuity Planning (BCP) & GCP.
Ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators.
Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management.
- Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data.
- Assist with the management of study supplies and organize shipments.
- Create, update, track, and maintain study-specific trial management files, tools, and systems.
- Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators' meetings).
- Co-ordinate meetings with clients, investigators, and project team, including taking minutes.
- Ensure compliance with Covance S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work.
- Provide input in writing Monitoring Conventions as assigned.
- Assist in submissions and notifications to Ethics Committees and Regulatory Authorities.
General On-Site Monitoring Responsibilities:
- Assist Senior CRAs, CRA-2 and CRA-1 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability).
- Initiate, monitor and close out clinical investigative sites under direct supervision from Clinical Research Associates 1 and 2, Sr. Clinical Research Associates,
Professional Experience:
Hospital worked : St. Thomas Hospital, Chennai. (6yrs from 2001 to 2007)
Years of working : Jan2001-Apirl2007 Position : Chief Physiotherapist (HOD)
Organization worked: Accenture Services Pvt. Ltd., Chennai, Tamilnadu. (4 yrs from 2007 to 2011)
Years of working : May 2007 – March 2011
Designation : Clinical Trail Co-coordinator (MedDRA and WHO)
CURRENT ORGANIZATION:
Organization Working: at Novartis for Cognizant, Hyderabad
Designation: Clinical Trial Co-coordinator (March 2011 to till date)
TECHNICAL SKILLS:
Primary Skills - Thesaurus Management System (TMS), Auto- coder ,EDC,J- Review
Operating Systems - MS-DOS, WIN 98/XP.
Databases - Oracle clinical.
TMS, GRT, SQL, I & J-Review and CREDI
Personal Details:
Date of Birth : 02.03.1977
Fathers Name : G.Manoharan
Mobile : +91-730*******
Email ID : ***********@*****.***
Passport number : EO88O332
WORKING LOCATION: HYDERABED (NOVARTIS FOR COGNIZANT PVT LTD)
CURRENT ADDRESS: 1081 Ayyappa Society Madhapur ,HYd - 81
Declaration
I hereby assure you that all information is given above are best of my true knowledge. If, I get a chance to work in your Organization, I will do my best to develop the concern and satisfy my superiors.
Place: Hyderabad Yours faithfully, Dr.M.DHINAKARAN
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