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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 Open Clinica :-
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 |
Advance Program in Clinical Research & Management (Clini India) | |||
B.Sc. | |||
Intermediate | |||
S.S.C |
IT PROFIENCY
MS Office
Oracle, SAS, SPSS softwares
ACTIVITIES:
Presented many seminar/round table meet during GraduationPERSONAL DETAILS
Date of Birth
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Nationality
Language known
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