Prajakta Naik Email & Phone Number | An experienced results-minded professional with over 12 years of diverse clinical research experience from managing early phase to late phase clinical trials including bioequivalence trials and preparation of Module 4 and Module 5. In-depth knowledge of conduction and management of clinical trials in multiple therapeutic areas including their design, development, coordination, data and project management from protocol development/review, approval through to activation, follow-up and trial closure. Outstanding and thorough knowledge of GCP and GLP guidelines. Well versed with principles of Computer System Validation and a CSV expert for qualification of cGLP softwares used. Strong analytical approach with an ability to multitask and identify and resolve all clinical trial related issues. Successfully completed first USFDA inspection of organization with minimum observations. Expertise and extensive experience in the following: • Conduction of BA/BE studies • Quality Assurance audits • Study protocol design & implementation • Vendor qualification • Module 4 and Module 5 • GCP/GLP related compliance • Clinical trial project management • Site selection & Monitoring • Risk based Management review

Prajakta Naik

An experienced results-minded professional with over 12 years of diverse clinical research experienc...
India

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Prajakta Naik’s Email prajakta.naik@unichemlabs.com

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Prajakta Naik’s Location India

Prajakta Naik’s Current Industry Enem Nostrum Remedies

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Work Experience

Enem Nostrum Remedies

Agm_Quality Assurance

2019-10-01 00:00:00 - Present

Alkem Laboratories

Sr. Manager Cqa

2017-05-01 00:00:00 - 2019-10-01 00:00:00

Enem Nostrum

Manager Quality Assurance

2014-08-01 00:00:00 - 2017-05-01 00:00:00

Drug Monitoring Research Institute

Dgm - Quality Assurance

2012-06-01 00:00:00 - 2014-07-01 00:00:00

Unichem Laboratories

Asst. Manager

2010-06-01 00:00:00 - 2012-03-01 00:00:00

Sandoz

Gcp Complaince Specialist

2009-06-01 00:00:00 - 2010-06-01 00:00:00

Macleods Pharmaceuticals

Quality Assurance - Bioequivalence Division

2007-02-01 00:00:00 - 2007-08-01 00:00:00

Raptim Research

Quality Assurance

2006-01-01 00:00:00 - 2007-01-01 00:00:00

Tata Consultancy Services

Quality Control For Gsk Project

2007-01-01 00:00:00 - 2007-01-01 00:00:00

Jbcpl

Regulatory Affairs

2005-01-01 00:00:00 - 2006-01-01 00:00:00

Skills

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Languages

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FAQ About Prajakta Naik

Prajakta Naik is located at
India

Prajakta Naik is a An experienced results-minded professional with over 12 years of diverse clinical research experience from managing early phase to late phase clinical trials including bioequivalence trials and preparation of Module 4 and Module 5. In-depth knowledge of conduction and management of clinical trials in multiple therapeutic areas including their design, development, coordination, data and project management from protocol development/review, approval through to activation, follow-up and trial closure. Outstanding and thorough knowledge of GCP and GLP guidelines. Well versed with principles of Computer System Validation and a CSV expert for qualification of cGLP softwares used. Strong analytical approach with an ability to multitask and identify and resolve all clinical trial related issues. Successfully completed first USFDA inspection of organization with minimum observations. Expertise and extensive experience in the following: • Conduction of BA/BE studies • Quality Assurance audits • Study protocol design & implementation • Vendor qualification • Module 4 and Module 5 • GCP/GLP related compliance • Clinical trial project management • Site selection & Monitoring • Risk based Management review

Prajakta Naik currently works in the Enem Nostrum Remedies |

No Languages Available

Prajakta Naik has prior
experience in the following industries:
Alkem Laboratories | Enem Nostrum | Drug Monitoring Research Institute | Unichem Laboratories | Sandoz | Macleods Pharmaceuticals | Raptim Research | Tata Consultancy Services | Jbcpl

Prajakta Naik has the following professional experience:
Enem Nostrum Remedies | Alkem Laboratories | Enem Nostrum | Drug Monitoring Research Institute | Unichem Laboratories | Sandoz | Macleods Pharmaceuticals | Raptim Research | Tata Consultancy Services | Jbcpl