Manish Bhardwaj

Experience

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  Accenture

  Mar 2015 - May 2020

  • Execution of service delivery & service performance management of Research, Regulatory and clinical R&D applications.• Service Integration with active involvement of vendors, support teams, Business, IT Infrastructure & other stakeholders.• Process & Risks & Quality Control, Escalations Management, GDPR Assessment.• Application Life Cycle management to ensure technological readiness adherence to service value for client.• Delivery of IT service demand forecast as baseline for budget planning and calculation.• Project planning/budgeting, risk assessments, requirements discovery, Resource customer programs; including all ongoing commercial aspects such as contracts, invoicing, and related costs.• Audit supervision from BT end in Regulatory Domain.• Documentation and Process Qualification consultant against GXP and Non-GXP Pharma standards.• Release planning and deployment in Production environments with adherence to Change Management Process.• Service reporting (MSR) for GRED, GRA & Drug Safety Domain covering performance, service improvements, quality aspects and processes.• License/Infrastructure renewal, Cost saving by release(decommission) of inactive/retired system/service.• Ensuring proper documentation & training materials and organize/provide training. Annual periodic renewal of PRR, DRP, QR documents.• Responsible for delivering excellence in all aspects of the service delivery function within an ITIL derived framework.• ITGSS items management and identification of resolutions for non-conformance. Show less • 1.5 Years working experience in end to end Service Operation & Support in well-established Pharma Client.• SME for RIMS(Liquent Insight Manager) , agEncoder , Mosaic(Titian Compound Logistics) , Open-lab , Simcyp , Empower in R&D Portfolio.• Applications support: Supervise web server management and maintenance, applications implementation, applications adaptation, systems integration, hosting, domains.• Pharma regulatory business process knowledge, worked in Regulatory information management system(RIMS)as IT SME including RIMS analytical module(WebFocus).• Experienced in functioning of IT operations control tool like HPSM/SNOW, SCDB, CMDB etc.• Change & Release management specialist in Application development or change cycle following GXP and NON-GXP standards.• Incident & Problem Management against SLA targets.• Root cause analysis and CAPA preparation.• Qualification documentation expertise like QP, TS, IQP, IQR ,FIT etc.• End to end decommission of the retired applications.• Maintaining Application Admin guide, User and Operational Manual. • Application Qualification Document preparation and approval in electronic tools like Mango etc.• Weekly FAR and Review meeting with Business.• Driving/Mentoring changes in CAB meeting for Application CR. • Handling L2/L3 level support across R&D applications.• Participated in solution/planning approach in active applications Like FK,CH migration for RIMS.• Deep business process understanding in delivering required Analytical/Data based on SQL scripts. Show less

  • Application Development Senior Analyst || GSK (Employer - Accenture)

    Aug 2019 - May 2020

  • Service Delivery Manager || Merck KGaA (Employer - Accenture)

    Jan 2017 - Aug 2019

  • Application Development Analyst || Merck KGaA (Employer - Accenture)

    Mar 2015 - Dec 2016
• 

  Novo Nordisk

  May 2020 - Dec 2021

  Advanced Business Analyst

  • Managed IT support and maintenance of RIMS system for Regulatory Solutions at Novo Nordisk.• Led Veeva RIM configuration and support as Vault Owner, ensuring seamless submission and registration processes.• Collaborated with product manager to translate roadmap features into well-defined requirements for Agile development.• Acted as IT representative for audits and inspections, ensuring compliance and risk management.

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  Accenture DACH

  Dec 2021 - now

  Vault Clinical Project Lead || Novartis (Employer - Accenture)

  • Functional Lead SME for R&D clinical transformation project, driving end-to-end delivery from eTMF to CTMS• Spearheaded business requirements gathering and formulated detailed user requirements in JIRA for Vault eTMF/SSU, ensuring seamless collaboration with the testing team for comprehensive coverage and defect resolution• Acted as a Vault platform technical expert, facilitating business workshops and aligning tool capabilities to ensure successful and efficient implementation of client requirements.• Delivered projects on schedule through close collaboration with Veeva, clients, validation teams, and other stakeholders, adhering to agile methodologies• Designed and executed a robust technical and business go-live plan, coordinating with integration, testing, client, and Veeva teams to ensure smooth transitions.• Led the User Access Management (UAM) stream, strategically planning and executing the creation and migration of users into the new CTMS environment. Show less