Deepak Shukla

About Deepak Shukla

Specialties: Extensive Knowledge in:•International Conference on Harmonization-Good Clinical Practices.•Applicable Regulatory Guidelines (ICMR and Schedule Y).•Good Clinical Practices (GCP).•Clinical trials and regulations, GCP and Regulatory compliance for Pharma and Biotech products.•Clinical Ward Monitoring•Adverse Drug Reporting and Casualty assessment•Patient Counselling•Participating in ward rounds

Experience

1. Clinical Research Associate

   IQVIA

   Feb 2016 — Present

   Perform site selection (if applicable), initiation, monitoring and close-outvisits in accordance with contracted scope of work and good clinicalpractice.•If applicable, may be accountable for supporting development of projectsubject recruitment plan on a per site basis. Work with sites to adapt,drive and track subject recruitment plan in line with project needs toenhance predictability.•Provide monitoring visits and site management for a variety of protocols,sites and therapeutic areas.•Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoingproject expectations and issues.•Evaluate the quality and integrity of study site practices related to theproper conduct of the protocol and adherence to applicable regulations.Escalate quality issues as appropriate.•Manage the progress of assigned studies by tracking regulatorysubmissions and approvals, recruitment and enrollment, case reportform (CRF) completion and submission, and data query generation andresolution. May support start-up phase.•Create and maintain appropriate documentation regarding sitemanagement, monitoring visit findings and action plans by submittingregular visit reports, generating follow-up letters and other requiredstudy documentation.•Build awareness of features and opportunities of study to site.•Collaborate and liaise with study team members for project execution support as appropriate.

Education

• SRI GURU RAM RAI INSTITUTE OF TECHNOLOGY AND SCIENCE

  Master of Pharmacy, Clinical Pharmacy

  2009 — 2011

• No

  B. Pharma

  2009 — 2011

Skills

• Clinical
• Clinical Research Associates
• Clinical Monitoring
• CRO
• Inform
• Biotechnology
• Good Clinical Practice (Gcp)
• Regulatory Requirements
• Clinical Study Design
• Edc
• Clinical Trial Management
• Ctms
• Sop
• Fda
• Clinical Research
• Gcp
• Clinical Trials
• Ich-Gcp