Management Clinical Research

G. Haritha Kanthi

E-Mail: **************@*****.***

Phone: +91-990*******

OBJECTIVE

To achieve excellence in the field of clinical research and make significant contribution in its

emerging scenarios through proper utilization of conceptual ideas and skills.

PROFESSIONAL SYNOPSIS

Knowledge of (Clinical Research)

• Good Comprehension of FDA and CDISC guidelines, CIOMS, Good Clinical Practice (GCP),

International Conference of Harmonization (ICH) and other Regulatory guidelines (NDA).

• Roles & Responsibilities of Key Stakeholders.

• Subjects Informed Consent Form & Protocol Compliance.

• Basic knowledge on CRF Designing.

• Essential documentation in Clinical Research and Regulatory Submissions.

• Knowledge of 21 CFR, schedule Y and Good Clinical Data Management Practice

(GCDMP).

• Comprehensive knowledge of international drug safety and pharmacovigilance principles

and regulations.

• Clinical Trials Project Planning & Management.

Pharmacovigilance Skills

• Good Knowledge in Drug and Cosmetic act-Schedule Y and European Union rules and

regulation.

• Thorough understanding of MedDRA, casualty assessment, Safety data management,

pharmacovigilance planning.

• Good understanding in preparation of PSUR, ASR, DSUR and PADER.

• Reporting elements for SUSAR, ICSR and narrative writing.

SAS

• Fair Knowledge in SAS programming including merging SAS datasets, preparing and

cleaning data, SAS formats and informats.

• SAS functions, statements, Procedures like Proc Univariate, Proc Means, Proc t test, Proc

corr, Proc ANOVAs, Proc Reg.

EDUCATIONAL DETAILS

• Pursuing M. Sc in Clinical Research and Regulatory Affairs from Sikkim Manipal

University of Distance Education, Hyderabad, Andhra Pradesh, India.

• B. Pharmacy from Jawaharlal Nehru Technological University, Andhra Pradesh, India (First

Class), 2011 with 71.4%.

• Kakatiya Jr. Co-Op College, Hyderabad, Andhra Pradesh, India, 12 th with Bi.P.C. (First

Class), 2006 with 86.7%.

• Siddhartha High School, Hyderabad, Andhra Pradesh, India, 10 th (First Class), 2004 with

84.16%.

TECHNICAL SKILLS

Operating Systems : Win XP, Vista

Packages : MS-Office

Databases : MS Access

SAS MODULE : BASE SAS, SAS/SQL, SAS/GRAPH, SAS/ODS, SAS/STAT

WORK EXPERIENCE - (ORGANIZATION AND JOB DESCRIPTION)

Organization : Sanjeevani Life Sciences.

Designation : Executive Clinical Research

Duration : July 2011-Sep 2012

Responsibilities: As an Executive, provide technical and process-related support to team

(clinical operations) and performing documentation and QC activities, ensuring compliance

with relevant regulations and Standard Operating Procedures (SOPs).

• Developing and Review protocol with QC team.

• Developed, reviewed and revised Local and Global SOP’s Clinical trial

management and clinical data management.

• Perform QC of documents prepared by other writers.

• Worked on documents across therapeutic areas.

• Worked with senior medical writers to prepare documents that meet client

expectations.

• Preparation of PSURs and SUSARs.

• Organizing Investigator meetings.

• Making of related documents for Clinical Trial Administration and

management and Regulatory Affairs.

• Generating updates of Clinical Trial with senior management and client.

• Experience in designing CRFs, DCF, SAE form and DMP.

• Hands on experience in Discrepancy Management and Query

Management.

CERTIFICATION

• Certified training in MEDICAL WRITING AND REGULATORY AFFAIRS from

SANJEEVANI LIFE SCIENCES, Hyderabad (INDIA) (2011).

• Certified training & internship in CLINICAL SAS, CDM AND PHARMACOVIGLANCE from

SANJEEVANI LIFE SCIENCES, Hyderabad (INDIA) (2011).

• Certified in HANDLING OF ANALYTICAL EQUIPMENTS (HPLC, GC and UV) at

Pharma Train, June 2011, Hyderabad.

• 2months certification course on DRUG MANUFACTURE, QUALITY CONTROL,

REGULATORY AFFAIRS AND QUALITY MANAGEMENT aspects at Hi-Tech

Institute of Advanced Pharmaceutical Sciences (Natco House), June 2010, Banjara

Hills, Hyderabad.

• Industrial training in CHEMICAL DIVISION of Natco Pharma Limited, Mekaguda

Village, Mahaboobnagar in May 2010 (30days).

• Participated in Workshop on Pharmacology- Experimental Methodology, Feb 2011,

Hyderabad.

• Participated in various National level poster presentations.

PERSONAL DETAILS

• Father’s Name : G. K. M .S. Sai Babu

• Date of Birth 22nd April, 1989

:

• Sex : Female

• Languages Known : English, Hindi & Telugu

• Hobbies : Music, Reading books

DECLARATION

I hereby declare that above information is correct to the best of my knowledge and belief.

Place: Hyderabad G. Haritha Kanthi.

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