Virendra Narayan Shukla
Institute of Management Technology, Ghaziabad
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Virendra Narayan Shukla is a highly experienced Clinical Research professional with over seven years of expertise in all study start-ups, regulatory approval and compliance, and site management. He has worked in various regions for clinical trial start-ups, regulatory submissions, and site closeouts. Virendra has extensive knowledge of ICH-GCP and international and national guidelines. He has held senior positions at ICON Strategic Solutions, Premier Research, Parexel, Syneos Health, and GE Healthcare. Virendra is skilled in CRA training, oversight, and site relations dynamics. He is currently based in Allahabad, India.
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About
More than seven years of experience in Clinical Research, with expertise in overall all study start up, regulatory approval and compliance, subject recruitment and retention, complete site management including clinical monitoring, worked in capacity of Senior CRA, Microbiology- CRA, Lead- CRA, Regional CRA. Worked for U.S and Asia pacific (India, Philippines, Indonesia, Thailand, Malaysia and Vietnam) regions for Clinical trial start up, Regulatory submissions, on site monitoring and site close outs.Expertise in CRA training, on site CRA oversight, handling issues and CRA - site relations dynamics. Audit preparations at sites with global overview and hands on experience. Managing the report review task with time bound deliverable.Specialties: Cardiovascular, Endocrinology, Infectious Disease, CNS, Psychiatry and Oncology. In depth knowledge of ICH-GCP & various international and national guidelines.
...See MoreWork Experience
Senior Site Manager
Pharmaceutical Manufacturing
Virendra Narayan Shukla's Professional Milestones
- Consultant - Clinical Operations (2014-04-01~2014-12-01): Enhanced operational efficiency through strategic planning and implementation of streamlined processes.
- Senior Clinical Research Associate (2016-01-01~2016-10-01): Conducted groundbreaking research, driving advancements in the field of clinical study.
Education
Operations
2009-2011Skill
Ich Gcp
Clinical Monitoring
Clinical Trials
Regulatory Submissions
Oncology
Gcp
Cro
Clinical Research
Pharmacovigilance
Edc
Ctms
Clinical Operations
Pharmaceutical Industry
Good Clinical Practice
Clinical Development
Regulatory Affairs
Standard Operating Procedure
Protocol
Clinical Research Associates
Psychiatry
Trial Management
Sop
Medical Writing
Infectious Diseases
Cro Management
Initiation
Endocrinology
Crf Design
Clinical Study Design
Therapeutic Areas
Inform
Patient Recruitment
Drug Development
Vaccines
Electronic Data Capture
Oracle Clinical
Clinical Pharmacology
Clinical Trial Management System
Pharmaceutical Manufacturing
Line Management
Certification
Colleagues
Claudia Chavarro
Senior Director | General Manager
Cara Lansden
Director Clinical Operations
Cathy Lane
Executive Director | General Manager | Clinical Operations | Icon Strategic Solutions
Sung In Hong
ICON ISS Vice President in APAC
Jennifer Alamo Linnell
Vice President | Human Resources Business Partner
Other Named Virendra Narayan Shukla
Frequently asked questions
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Virendra Narayan Shukla's social media include: Linkedin,
Virendra Narayan Shukla works for ICON Strategic Solutions
Virendra Narayan Shukla's role in ICON Strategic Solutions is Senior Site Manager
Virendra Narayan Shukla works in the industry of Pharmaceutical Manufacturing
Virendra Narayan Shukla's colleagues are Claudia Chavarro,Cara Lansden,Cathy Lane
Virendra Narayan Shukla's latest job experience is Senior Site Manager at ICON Strategic Solutions
Virendra Narayan Shukla's latest education in Institute of Management Technology, Ghaziabad