Amresh Kumar

Amresh Kumar Email and Phone Number

Associate Director - Clinical Data Management @ Novartis India
bombay, maharashtra, india
Amresh Kumar's Location
Hyderabad, Telangana, India, India
About Amresh Kumar

- As Functional manager - coaching, mentoring, and developing the assigned team members• As Program Data manager: Provides Data Management leadership for one or more assigned programs/projects or indications. • Demonstrates a business understanding of the compound profile to identify and assist in successful application of consistent data management processes and documentation across assigned programs, i:e ensuring consistency across data quality plans • Develops an understanding of CDISC or other recognized industry standards and how these impacts the programming team. Ensures consistency of program level standards • Communicates and negotiates effectively with all other Program level team members. Primary point of contact for DM at the GPT level. • Maintains awareness of the status of startup, conduct and finalization activities for all trials within assigned program(s) Tracks and requests necessary resources. Ensures the key study risks & issues are shared in the Project Review Meeting led by DO DUs & Sr GHs/GHs. • Demonstrates an effective application of knowledge across all DM scenarios. Is able to provide solutions to effectively meet timelines• Manages effective escalation of issues in order to keep stakeholders appraised of DM activities and proposed resolutions• Supervises and drives the overall DM timelines across assigned programs. Reviews the Data Management Metrics on the assigned Program. • Ensures that DM associates on the program are aware of the risks, priorities, goals and impact of the work contribution. • Develops risk management strategies to prevent data quality issues from derailing projects • Represents Data Management at cross functional forums, meetings and provides timely feedback to partners• Understands Health Authority requirements and is able to prepare for and participate in Health Authority inspections and audits as required

Amresh Kumar's Current Company Details
Novartis India

Novartis India

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Associate Director - Clinical Data Management
bombay, maharashtra, india
Website:
novartis.in
Employees:
832
Amresh Kumar Work Experience Details
  • Novartis India
    Associate Director - Clinical Data Management
    Novartis India Nov 2021 - Present
    Hyderabad, Telangana, India
  • Novartis India
    Senior Program Clinical Data Manager
    Novartis India Apr 2018 - Oct 2021
    Hyderabad, Telangana, India
  • Novartis India
    Program Clinical Data Manager
    Novartis India Sep 2017 - Mar 2018
    Hyderabad, Telangana, India
  • Novartis India
    Senior Clinical Data Manager
    Novartis India Sep 2014 - Aug 2017
    Hyderabad, Telangana, India
  • Novartis India
    Clinical Data Manager
    Novartis India Apr 2012 - Aug 2014
    Hyderabad, Telangana, India
  • Novartis India
    Clinical Data Specialist
    Novartis India Aug 2010 - Mar 2012
    Hyderabad, Telangana, India
  • Tata Consultancy Services
    Senior Process Associate
    Tata Consultancy Services Feb 2009 - Jul 2010
    Mumbai, Maharashtra, India
    • Handled Phase-3, and phase-4 RDC studies. • Trained in Inform and perform the data validations.• Well trained in Clinical data loading (CDL).• Perform Efficacy Data Checks and Safety Data checks for study; prepare reports to be sent to onshore.• Check and report for wrongly failing and required validations.• Suggesting Study specific guidelines or changes in the existing ones.• Provide expert comments and feedback on quality initiatives in Client meeting.• Ensure timelines set by the client in terms of pages produced and clean patient delivery are met.• Ensuring Lock and freeze of the Study within the time line. Assisting team leaders/SME in resolving complex issues.• Interact with on-shore resources regarding data quality issue on a regular basis.• Provide information on the quality of Locked database within the required timeframe before further actions are carried out.

Amresh Kumar Education Details

Frequently Asked Questions about Amresh Kumar

What company does Amresh Kumar work for?

Amresh Kumar works for Novartis India

What is Amresh Kumar's role at the current company?

Amresh Kumar's current role is Associate Director - Clinical Data Management.

What schools did Amresh Kumar attend?

Amresh Kumar attended Cmr Institute Of Management Studies.

Who are Amresh Kumar's colleagues?

Amresh Kumar's colleagues are Venkata Pradeep Kadiyam, Gayathri Yerra, Ramesh Dumpala, Falin Majmudar, Sabyasachi Ghadei, Aparna Rajan, Ravinder Reddy Devarapalli.

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