premchand pastula

Angestellt, Clinical Trial Specialist, MorphoSys AG
Munich, Germany

Fähigkeiten und Kenntnisse

Clinical Trial Management
Clinical Trial Documentation
TMF SME
Clinical Project Management
Agile Operating Methodology
Alteryx Designer
Quality Audits
Inspection Readiness
HA and EC Submissions
CSR Section 16.1
eDMS Business SME
FDA 21 CFR Part 11
EMEA Guidelines
ICH GCP Guidelines
Java Eclipse
MySQL Workbench
Metrics
KPI
PQ Script Writing
Proton Test Instance Management
System Development Life Cycle (SDLC)
MS Office Tools
SOP's Authoring
Templates Authoring
Training Slides Preparation and Delivery
Vendor Management
Clinical Research
Clinical Trials
Document Management Systems
Document Lifecycle Management
TMF Reconciliation
Clinical Drug Supply Tracking
Team Leading
Recruitment
Support

Werdegang

Berufserfahrung von premchand pastula

  • Current 6 years and 11 months, since Jul 2019

    Clinical Trial Specialist

    MorphoSys AG
  • 1 year, May 2018 - Apr 2019

    Expert Clinical Research Specialist

    Novartis

    Deliverable's: Clinical Trial Management Support Clinical and Regulatory Document Management Project Management TMF Migration, Integrations Clinical Trial Process Automation and Optimization

  • 3 years and 1 month, Apr 2015 - Apr 2018

    Senior Clinical Research Specialist

    Novartis

    Deliverable's: Clinical Trial Management Support TMF SME HA and EC Submissions Project Management

  • 1 year and 9 months, Jul 2013 - Mar 2015

    Clinical Research Specialist

    Novartis

    Deliverable's: Clinical Trial Management Support Clinical Document Management HA and EC Submissions

  • 1 year and 9 months, Oct 2011 - Jun 2013

    Associate Document Manager

    Novartis

    Deliverable's: Clinical Document Management Document Archiving, Scanning Document Management System Business Administrator

  • 9 months, Feb 2011 - Oct 2011

    Intern - Associate Document Manager

    Novartis

    Deliverable's: Clinical Document Management TMF Archiving, Scanning Clinical Publishing Document Management System Business Administration

Ausbildung von premchand pastula

  • 1 year and 1 month, Jun 2016 - Jun 2017

    Clinical Trial Management

    James Lind Institute, Singapore

    Clinical Research, Clinical Trial Management and Clinical Development

  • 2 years and 1 month, May 2015 - May 2017

    Pharmacy and pharmaceutical technology

    Himalayan University, India

    Pharmaceutical Management and Research

  • 4 years and 1 month, Aug 2006 - Aug 2010

    Pharmaceutical Sciences

    Acharya Nagarjuna University

    Pharmaceutical Chemistry, Pharmaceutical Engineering, Biochemistry, Microbiology and Pharmaceutics etc

Sprachen

  • English

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    A1-A2 (Grundkenntnisse)

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