shaktiprava Mishra

Clinical Data Analyst at PAREXEL International

Location
Hyderabad, Andhra Pradesh, India
Industry
Pharmaceuticals
Previous
  1. Somnia Anesthesia Solution,
  2. AU-KBC research center,
  3. Aurous HealthCare R & D Private Limited
Education
  1. Anna University, MIT campus, Chennai
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Background

Summary

Currently working as a clinical data analyst in Parexel International, Hyderabad

Total 6 years of working experience.

Previously worked as a quality reviewer in healthcare industry.

Also worked as quality research associate in a clinical trial organisation.

Specialties: Drug development process, Clinical trial operation, quality assurance, Training management, Clinical data analysis and management

Experience

Clinical Data Analyst

PAREXEL International
– Present (1 year 4 months)Hyderabad Area, India

CLINICAL QUALITY MANAGEMENT PROCESS SPECIALIST

Somnia Anesthesia Solution
(2 years)Chennai, India

Data quality analysis, ensuring data accuracy and completeness, attention to details of data for annual and interim report, trend analysis, User acceptance testing on database, external client interaction, working under tight deadlines,

VISITING LECTURER for clinical trial management course

AU-KBC research center
(2 years 11 months)Chenai

teaching students on good clinical practice, essential documetns in clinica trials, clinical trial supply chain management, investigator's brochure.

SENIOR RESEARCH ASSOCIATE QUALITY ASURANCE

Aurous HealthCare R & D Private Limited
(1 year 9 months)Chennai Area, India

Reviewing clinical trial documents, providing expert comments based on regulatory compliance norms
Reviewing clinical trial data and generating DCF. Coordinating with CRAs for resolving the discrepancies.
SOP writing, reviewing and management, clinical trial document control and retention.
Managing clients at front end, clarifying technical issues, representing company to sponsor and auditor as a management representative.
Preparation of quality documents such Quality Manual, Training Manual. And other standard documents and forms used in clinical trials.
Internal audit, trail site audit, vendor audit and evaluating non conformity following to audit, suggesting CAPA. Ensuring the accomplishment of corrective actions in time.
Experienced in ISO auditing and documentation.
Experienced in investigator site audit for Phase III and IV clinical trials
Internal staff audit & training
External vendor audit such as clinical Lab

CLINICAL RESEARCH ASSOCIATE

Aurous HealthCare R & D Private Limited
(8 months)Chennai Area, India

Preparing clinical trial document such as protocol, CRF, ICD, CSR, regulatory documents
Coordinating with ethics committee for submission and approval of trial documents
Preparing site feasibility questionnaire, selection of site, selection of investigator
Coordinating with trial site, trial site initiation, trial site training
Trial site monitoring, CRF review, drug accountability
Maintaining trial site master file
Coordinating with auditor and quality assurance team and supporting them in every quality assurance activities

Senior lecturer

MITS eng. college, ORISSA
(2 years 7 months)

Lecturer in Biotech division.

Courses

Somnia Anesthesia Solution

  • SIX-sigma, green belt

Independent Coursework

  • PG certificate in Clinical Trial Management

Skills

  • Clinical Data Management
  • GCP
  • Medical Writing
  • ICH-GCP
  • Sop
  • CLINICAL TRIAL AUDITING
  • QUALITY ASSURANCE...
  • Drug Development
  • IRB
  • CAPA
  • Data Management
  • Quality Assurance
  • Lifesciences
  • Validation
  • Clinical Monitoring
  • Data Analysis
  • Six Sigma
  • ISO 9001 2008
  • Essential documents in...
  • TMF and ISF filing
  • Clinical trial supply...
  • See 6+  See less

Education

Anna University, MIT campus, Chennai

PG certificate in clinical trial management, Clinical research

Publications

Genotypic characterization of Escherichia coli

Text book - Microbial Biotechnology: Methods and Applications

Additional Info

  1. Interests

    • clinical research,
    • clinical data management software,
    • clinical trial auditing,
    • Teaching,
    • biotechnology,
    • traveling.
  2. Personal Details

  3. Advice for Contacting shaktiprava

Honors & Awards

Published an interview article in “THE WEEK” Aug 15th 2009 issue.
Honorary guest lecturer in Anna University for CR course.

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