Management Pvt Ltd

GIRISH G. HIRPARA

Mobile: 099********

Email: ************@*****.**.**, ***************@*****.***,

Seeking managerial assignments in Clinical trial Monitoring and

management /

Operations with an organization of repute

> A result-oriented professional with more than 7 years of experience in

designing, execution, monitoring and management of a Clinical trial of

Phase I, II, III and IV; including BABE studies

> Competent in developing & streamlining systems with proven ability to

enhance operational effectiveness and meet operational goals within

the time & quality parameters

> Adroit in developing and implementing systems and procedures to

maximize efficiency in operations

AREAS OF EXPERTISE Clinical Trial

> Designing:- Preparation of the clinical study

Protocol, ICF, CRFs and Appendices

> Execution:- Site Selection, Initiation, Recruitment, Monitoring,

Close out, tracking, compliance and communications

Team Management

> Leading & monitoring the performance of the team to ensure

efficiency in operations & meeting of individual & group targets.

> Managing study teams to ensure the timelines and quality of

deliverables.

Strengths as a Clinical Research Professional:

> Highly experienced with clinical research processes and

regulations

> Clear understanding of various therapeutic segments

> Expert in Protocol designing, planning and implementing with high

degree of compliance

> Have good leadership skills

> Expert in handling non- performing sites

> Ability to prioritize multiple tasks and achieve timelines

> Excellent presentation and communication skills

EMPLOYMENT PROFILE

June '13 - Present at GVK Bioscience Pvt Ltd.,

In Clinical Trial Department; as a Sr. Clinical Research

Executive(Team Leader)

Strategic Role:

> Leading, monitoring and mentoring CRA team to achieve targets and

quality of clinical projects in line with study budget and timelines.

> Elevate understanding and adherence of clinical trial SOPs and

regulations through intensive and frequent trainings, monitoring and

motivation to study teams.

> Implementing systems and tools for tracking and monitoring of various

activities of clinical studies to elevate the level of quality

standards and management.

Operational Activities:

> Planning for new studies and preparation of study budgets /quotations

> Preparation of Clinical Trial Protocols, CRFs, ICFs and appendices

> Primary CRA contact on individual projects

> Site Feasibility, Site Selection, Site Initiation, routine on site

monitoring and Site Close out visits for ongoing studies and

registering a study to CTRI

> Perform the monitoring activities with a high degree of proficiency

and autonomy

> Collaborate with CRA on site issues/actions

> Manage in-house site specific files

> Update all relevant tracking system on regular basis

> Maintain team list and sponsor / vendor details

> Performing clinical study activities on regular basis:

> Review recruitment plan and enrolment updates

> Address/resolve issues pending from the previous visit

> Verifying that source data/documents and other trial

records are accurate, complete, and maintained

> Verifying that Adverse events, concomitant medications, and

inter current illnesses are reported in accordance with the

protocol on the CRFs

> Communicating deviations from the protocol, SOPs, GCP, and

the applicable regulatory requirements to the investigator

> Managing site staff assignment

> Handling study drug and other supplies on site

> Follow-up on data entry and DCFs

April '11-June '13 at Cadila Pharmaceuticals Pvt Limited,

In Clinical Research Department as a Asst. Manager

> Monitoring and auditing Clinical Trials and BA-BE studies, to assure

adherence to Good Clinical Practice and compliance with the Protocol

and SOPs by study team

> Manage/advise teams in therapeutic areas of proficiency as required or

appropriate

> Function as Lead CRA for clinical studies, coordinating CRAs,

reviewing monitoring reports

> Provide mentoring and coaching to colleagues and site staff when

needed

> Design monitoring tools as requested

> Provide support for the design of CRFs and protocols as

requested

> Develop monitoring plans when required

> Actively participate in study team meetings

> Monitoring eCRF

> Preparation Study protocol, ICF, CRF, CSR etc

> IP Management, Document compliance

> AE, SAEs Management

> IEC, Sponsor, & Regulatory Communication

> Actively participate in investigator meetings

> Conduct training for colleagues or study team as requested

> Manage a cost centre and implement appropriate actions to keep

within budget

December '06- April' 11 at BA Research India Ltd.,

In Clinical Department; as a Clinical Research Associate

> Mentoring study team on SOPs, GCP and relevant clinical

Research regulations, establishing clear understanding for clinical

conduct to study team

> Evaluate the quality of study site for study conduct in line with the

protocol and adherence to applicable regulations and responding audit

finding of the Protocol and clinical data

> Developing and revision of SOPs

> Preparation of Clinical Study Protocol, including BABE Studies,

> Provide support for the design of CRFs and protocols as

requested

> Develop monitoring plans when required

> Actively participate in study team meetings

> Preparation Study protocol, ICF, CRF, CSR etc

> IP Management, Document compliance

> AE, SAEs Management

> IEC, Sponsor, & Regulatory Communication

> Actively participate in investigator meetings

> Conduct training for colleagues or study team as requested

> Manage a cost centre and implement appropriate actions to keep

within budget

> Preparation Study protocol, ICF, CRF, CSR etc

> IP Management, Document compliance

> AE, SAEs Management

> Reporting of subject's safety related issues (Adverse event reporting

and communicating to Ethics committee and Sponsor)

> Maintaining source data and case Report forms, including study

specific logs and forms and updating Trial

> Master File

> Data Quality Control & Quality Assurance

THE ATTAINMENTS:

> Have been appreciated for excellent work at BA Research India Ltd.

> Have also been appreciated for meeting the deadline with consistency

at BA Research India Ltd

> Have been appreciated for excellent team work for eCRF at GVK

Biosciences Pvt LTd.,

CONCISE OUTLINE:

NUMBER OF

PROJECTS 06

THERAPEUTIC AREA

PSYCHIATRY, RESPIRATORY, VACCINE, ONCOLOGY

COUNTRY INDIA,

VISIT TYPE PSSV SIV RMV COV

NUMBER OF VISITS 411 25 49 10

VISIT EXPERIENCE RECORD IN RESPECTIVE THERAPEUTIC AREA

THERAPEUTIC AREA PROJECT MONITORING

ACRONYM INDICATION SITES TYPE

PSSV SIV RMV COV

PSYCHIATRY PHASE III MDD 07 INDIA 12 07 12 00

RESPIRATORY PHASE IV PTB 09 INDIA 13 08 15 02

PHASE IV PTB 02 INDIA 06 04 02 00

VACCINE PHASE I SEASONAL 02 INDIA 05 03 10 04

INFLUENZA

VACCINE PHASE I H1N1 02 INDIA 05 03 10 04

CONFERENCE/ WORKSHOP ATTENDED

> Attended ICH-GCP Two-day Workshop conducted by Arkus Clinical trial

support solution in 2008 & 2010.

> Attended ICH-GCP Training conducted by ACEAS Ethics Committee in 2009.

> Attended ICH-GCP Training conducted by Mylan Pharmaceuticals in 2010.

> Attended ICH-GCP One-day Workshop conducted by Lambda Therapeutics

Research India Ltd in 2011.

> Attended ICH-GCP Training conducted by Cadila Pharmaceutical Ltd., in

2013

ACADEMIC CREDENTIALS

> Bachelor of Pharmacy from L.M.College of Pharmacy Ahmedabad;

[

PERSONAL MINUTE:

Full Name : GIRISHKUMAR GIRDHARBHAI HIRPARA

Address : D/132 Ashok Nagar Society, Opposite Prernatirth Derasar,

Behind ISRO, Ahmedabad- 380009 Gujarat, INDIA

Date of Birth : 13 August, 1984

Marital Status : Married

Languages Known

: English, Hindi & Gujarati

Hobbies : Reading, Traveling, Painting, Playing cricket, Music and

watching movies

Contact this candidate