Senior Analyst - Clinical Trial , GxP, 21 CFR Part 11, GCP and GLP, SQL

Posted 09 Mar 2020

Bangalore SBS, Karnataka - India

Req Id 204176

Details

A career at our company is an ongoing journey of discovery: our around 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.


Job Location: Electronic City, Bangalore

Shift Timings: 1:30 pm – 10:30 pm

The Senior System analyst will ensure service excellence is achieved according to our commitment to the BT user community in supporting our highly secure R&D platform. This position will ensure support continuity for HC business in APAC region as well as critical joint experiment support.

 

Responsibilities:

  • Experience in supporting applications in a global Clinical Trial Operations department. Candidate should have experience dealing directly with end users
  • Experience in supporting Clinical Trial Management Systems
  • Experience in supporting Electronic Data Capture Systems for a Global Clinical Operations Department
  • Experienced in database topics including SQL
  • Experience in report writing to satisfy end user requests
  • Plans, installs and maintains highly complex systems
  • Evaluates new applications and identifies systems requirements
  • Evaluates new IT developments and evolving business requirements and recommends appropriate system alternatives and/or enhancements to current systems.
  • Prepares communication and makes presentations on system enhancements and/or alternatives. Evaluates, optimizes, harmonizes and standardizes existing systems
  • Create and update system documentation. Monitors quality standards and ensures failure-free operation. Considers compatibility of different systems
  • Solves a range of straightforward problems through knowledge and technical experience in own discipline with a moderate level of guidance
  • Analyzes information and possible solutions and makes independent judgments, decisions and recommendations
  • Support the on-going regulatory compliance of the IT components for defined services
  • Review and approve regulatory system changes and documentation
  • Support periodic reviews of the entire system and compile related reports during operation phase
  • Support the on-going regulatory compliance of the IT components for defined services
  • Understands how the team integrates with other teams in order to achieve overall objectives of the area and builds knowledge of the organization, processes, customers and key business drivers
    Minimum Qualifications:
  • Minimum of 4-9 years of experience
  • Minimum of bachelor’s degree or applicable experience within information/Computer systems with focus on Qualification of R&D applications
  • Previous experience in the biotechnology/pharmaceutical or related industry with implementing and validating computer systems that manage regulated information
  • Working knowledge of IT infrastructure qualification processes and IT operating procedures
  • Knowledgeable in 21 CFR Part 11, GCP and GLP regulations
  • Thoroughly familiar with Quality & GxP IT compliance requirements
  • Excellent written and verbal communications skills
  • Working knowledge of information security and best practices

 


What we offer:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Apply Now

Let’s stay connected

Do you want to receive company news and information about career opportunities tailored to your preferences? Sign up here. You want to check the status of your application or change your candidate profile? Enter our job portal.

Redirect

You have accessed https://www.emdgroup.com, but for users from your part of the world, we originally designed the following web presence https://www.merckgroup.com.

Let's go

Share Disclaimer

By sharing this content, you are consenting to share your data to this social media provider. More information are available in our Privacy Statement