Dr. Mohammed Waris Ali

Experience

• 

  Excelra Knowledge Solutions Pvt Ltd

  Apr 2017 - Jul 2018

  Junior Research Analyst
• 

  Syneos Health (Previously INC Research/inVentiv Health)

  Jul 2018 - Sept 2019

  • Review of EDC data for completed visits and approving Payments to site for visits completed.• Approving costs as per backup documentation and activation or closure of site based on SIV/COV reports.• Action on items listed by sponsor on a priority basis by coordinating with Investigators, CRA’s and Accounts Payable team.• Negotiating extra adhoc costs on behalf of investigators and seeking sponsor approvals for a smooth ongoing of trial to make sure subject visits are completed without any hurdles.• Approving adhoc costs and visit payments to Sites in Medidata CTMS as per the backup documentation and contractual language.• Facilitating site payments with internal groups such as clinical operations, project management, accounts payable, accounts receivable, and site contracts teams. Coordinating with regional colleagues to ensure holistic global view of project payment/funding status Show less • Co-ordinating with PM and site support staff including Investigators and CRA’s to resolve any possible queries related to visits performed and payments made. Authorizing and approving all Ad-hoc payments and costs along with visits performed considering study budget, Backup documentations (IRB reports) and EDC reports.• Use of Medidata CTMS and Clinpay to verify site and investigator payments for visits performed. Going through data management metrics sheet and EDC data to make sure that all the visits performed are completed and the payments have been made accordingly. Show less

  • IMS Specialist-II

    Apr 2019 - Sept 2019

  • IMS Specialist I

    Jul 2018 - Mar 2019
• 

  Novartis

  Oct 2019 - Jun 2022

  • Responsible to Track trial progress up to site and country level, ensure CTMS is up to date. Address questions; escalate issues or critical findings to project lead• Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems: Update data, timelines, milestones, EC/HA authorizations, etc. for Countries and Sites on an ongoing basis.• Coordinate with CRO CRAs to obtain the Monitoring Visit dates and trip reports data in required templates and ensure that the data is updated in CTMS.• Responsible for Periodic review of TMF to ensure TMF is always complete and audit ready. Show less

  • Clinical Operations Specialist

    Mar 2021 - Jun 2022

  • Associate Clinical Operations Specialist

    Oct 2019 - Mar 2021
• 

  Eli Lilly and Company

  Jun 2022 - May 2023

  Senior Associate Manager

  The Clinical Trial Project Manager (CTPM) leads the cross-functional study team in the development and execution of clinical trials and is accountable both regionally and globally to deliver trial(s) with quality, on time, and within scope and budget. The CTPM Associate leverages project management, regional operational knowledge, clinical trial process leadership and expertise, and scientific expertise to drive actions and coordinate efforts to achieve or exceed these trial deliverables.

• 

  Syneos Health

  Aug 2023 - Aug 2024

  Senior Project Contract Associate

  PO manager handling contracts and negotiations on behalf of Amgen

• 

  Johnson & Johnson Innovative Medicine

  Sept 2024 - now

  Lead - Trial Delivery Manager

  The Manager, Trial Delivery Management MA DU (TDM) is responsible for the execution of study-level activities, creating and updating trial-specific documents, vendor oversight & delivery, compound training, and other activities.