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M.S RAGHAVAN
Mumbai
Cell No: 989797979
Email-id: msragav@rediffmailer.com
OBJECTIVE
Seeking challenging opportunities in Clinical Data management industry.
SYNOPSIS
Astute & result oriented professional with a sharp knowledge in Clinical Research & management domain.
Adept in delivering value-added Services to the organization by achieving Organization’s goal and providing creative way for new planning.
Possess excellent interpersonal, communication, team building & management skills.
Clinical Trials
ICH-GCP (Good Clinical Practices) Guidelines.
Clinical Safety Data Management (E2A) Guidelines.
CRA Responsibilities.
Informed Consent Process.
CRF data entry (manual, e-CRF).
Site initiation.
Source Data and Documents Verification.
Study Drug Accountability and Management.
DCF (solving queries).
Site Close Out and Termination of Trial.
Clinical Data Management
Good Clinical Data Management Practices (GCDMP).
Clinical Data Management System (CDMS) and Electronic
Data Management System/Remote Data Capture (EDMS/RDC).
Clinical Data Interchange Standards Consortium (CDISC).
Data management Plan.
CRF Designing (Paper base and E-CRF).
CRF Annotation Using SDTM model.
Writing Edit checks.
CRF Pages Tracking and Correction.
Data entry process (two pass entry).
Data Validation guidelines (Study specific, General).
Discrepancy Management (Cleaning Data).
Addressing Discrepancies (Types: - Unvaried, Multivariate, Manual).
Standard Operating Procedures (SOP’s) and Guidelines.
Trained on OpenClinica :
As Business Admin, trained on how to Administer Users, subjects, Studies,CRF’s To Manage Study, trained on Manage Users, subjects, Sites, Event Definitions, CRF’s, Discrepancies, Groups, View Study Events.
Also on Extract Data and Submit data.
Configure Protocol, Create Users and Assign to Protocol, Set up CRF’s, Define Study Events, Create Groups, Create Sites, and Add Subject.
Skill set
Developing and implementing strategies to achieve a larger market share and attract new segments.
Rapport building with Clients/Customers, budgeting for brand sales and other revenue.
Finalizing systems and procedures that achieve higher cost efficiency and customer and Organization satisfaction.
ACADEMIC CREDENTIALS
COURSE
College/Institute
Year of Passing
Percentage of Marks
P.G. Diploma
(Clinical Research &Data Management)
B.Sc.
Intermediate
S.S.C
IT PROFIENCY
MS Office
Operating system: Windows NT
Database: oracle
ACTIVITIES:
Presented many seminar/round table meet during Graduation
PERSONAL DETAILS
Date of Birth
Marital status
Nationality
Language known
Correspondence Address
E-mail
Mobile No.
(NAME)
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