CLINICAL DATA MANAGEMENT SAMPLE RESUME

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RESUME

M.S RAGHAVAN
Mumbai
Cell No: 989797979
Email-id: msragav@rediffmailer.com

OBJECTIVE

Seeking challenging opportunities in Clinical Data management industry.

SYNOPSIS

E  Astute & result oriented professional with a sharp knowledge in Clinical Research & management domain.

E  Adept in delivering value-added Services to the organization by achieving Organization’s goal and providing creative way for new planning.

E  Possess excellent interpersonal, communication, team building & management skills.

Clinical Trials

E  ICH-GCP (Good Clinical Practices) Guidelines.

E  Clinical Safety Data Management (E2A) Guidelines.

E  CRA Responsibilities.

E  Informed Consent Process.

E  CRF data entry (manual, e-CRF).

E  Site initiation.

E  Source Data and Documents Verification.

E  Study Drug Accountability and Management.

E  DCF (solving queries).

E  Site Close Out and Termination of Trial.

Clinical Data Management

E  Good Clinical Data Management Practices (GCDMP).

E  Clinical Data Management System (CDMS) and Electronic

E  Data Management System/Remote Data Capture (EDMS/RDC).

E  Clinical Data Interchange Standards Consortium (CDISC).

E  Data management Plan.

E  CRF Designing (Paper base and E-CRF).

E  CRF Annotation Using SDTM model.

E  Writing Edit checks.

E  CRF Pages Tracking and Correction.

 E  Data entry process (two pass entry).

E  Data Validation guidelines (Study specific, General).

E  Discrepancy Management (Cleaning Data).

E  Addressing Discrepancies (Types: - Unvaried, Multivariate, Manual).

E  Standard Operating Procedures (SOP’s) and Guidelines.

Trained on OpenClinica :-

E  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.

E  Also on Extract Data and Submit data.

E  Configure Protocol, Create Users and Assign to Protocol, Set up CRF’s, Define Study Events, Create Groups, Create Sites, and Add Subject.

Skill set

E  Developing and implementing strategies to achieve a larger market share and attract new segments.

E  Rapport building with Clients/Customers, budgeting for brand sales and other revenue.

E  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

  

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