PROFESSIONAL SUMMARY:

• 12+ years of core IT experience with pharmaceutical clients.
• Expertise in IGM (Information Governance Management) audit and application health check for GxP applications
• Knowledge of Service - Now tool. Worked extensively on incident management, Change Request (CRQ) management process
• Knowledge of BMC Remedy On Demand (RoD). Worked extensively on incident management, problem management, Change Request (CRQ) management process.
• Vendor Management - Working with external vendors on hosting & license, service provider report, purchase order and support.
• Coordinate with business stake holders for requirement clarification and gap analysis of architecture with respect to design and its implementation in the given environment.
• Thorough Understanding of Software Development Life Cycle (SDLC), involved in various phases like Requirements, Analysis/Design, Development and Testing.
• Project Management, Project Schedule, Project Tracking and Team Management
• Ability to maintain and build client relationships, frequent travel meeting one on one with clients, able to comfortably converse with all facets in the clients organization.
• Service Level Agreement and setting up the operational support organization.
• Driving and delivering Continuous Service Improvement(CSI) initiatives
• Representing the perspective of systems operations and maintenance on the project team.
• Work with Sales and Delivery teams to provide technical and business expertise
• Worked efficiently in OnSite/OffShore model
• Proficient in Clinical Trials Customization tools like InForm, ClinTrial and Oracle Clinical

TECHNICAL SKILLS:

Operating Systems: Windows 7/8, Windows XP

Languages: Veeva Vault, Drupal, Drupal Administration Services, Drupal Content Management Services, Java, J2EE, XML, JavaScript, WebLogic

Tools: InForm 4.5, ClinTrial 4.5, Oracle Clinical, Toad, BMC Remedy

PL: SQL and Oracle 12c

Domain Knowledge: Pharmaceutical and Life Sciences

PROFESSIONAL EXPERIENCE:

Confidential

Service Manager

Environment: Veeva Vault

Responsibilities:

• Support activities for implementing these programs, from RFP development to contract execution. This entails end-to-end ( Confidential to vendor) performance supervision (KPI, SLA)
• Provide specific instruction and guidance to teams; partner with the correct ITS colleagues to ensure proper review and launch activities
• Provide concrete recommendations to optimize programs based on data; continuously encourage teams to strive for success
• Act as a point of escalation for any immediate needs stemming from internal or external parties
• Maintain and consistently monitor analytics and learnings from pilot programs; translate findings into insights and actionable recommendations for programs in the future
• Participate in status calls with vendors and teams, maintain status sheets and provide reporting metrics to larger team
• User Access Management: Review & approve User Access Request and UAM activity (Periodic review of all users)
• Conduct system governance meeting with all stakeholders to prioritize enhancement, perform impact assessment and work with AMS (factory and Support) team to implement the change.
• Change management: responsible for scheduling functional requirements call till the deployment of the release.
• Incident management, problem management - review the tickets raised in Service-now till their closure and ensure the process is followed.

Confidential

Application/Service Manager (ASM)

Environment: WebLogic, Windows, LabVantage

Responsibilities:

• Application discovery & mapping, application "health" measurement & management, transaction-level visibility, and incident-related triage.
• Contract Management: Details of Operational Level Agreements (OLAs) with the service providers of underpinning IT services
• User Access Management: Review & approve User Access Request and UAM activity (Normal, Admin, Shared, Technical)
• Service Provider Management: SD creation and approval. KPI Reporting Requirements and Process
• System retirement and Back-up and Recovery Process
• License Management Process: Manage PO, license and hosting for external vendors
• IGM CMA Reporting, Auditing Requirements and Process, Periodic Review Assessment
• Security and Vulnerability Management
• CAB Meeting Overview. Create requirement gathering documents for CAB and present in CAB.
• Technology, Documents, Known risks and issues, Key Stakeholders
• Change management: responsible for scheduling functional requirements call till the deployment of the release.
• Incident management, problem management and service request management - review the tickets raised in RoD till their closure and ensure the process followed in IGM compliant.
• Revalidation of GxP applications in every 3 years

Confidential

Application Lead

Environment: Drupal, Acquia

Responsibilities:

• Responsible for leading the team of Confidential application.
• Requirement gathering and analysis and convey the same accurately to the team.
• Involved in design and development phase of the project.
• Analyze requirement, participated in solution designing.
• Status reporting and estimation for the project.
• Guiding team members and resolve technical issues.
• Handling project related documentation for the client.
• Interaction with the creative team and testing team for project execution.
• Requirement gathering and analysis and convey the same accurately to the team.
• Provides diagnosis and technical workarounds to production issues (incident resolution) and coordination with the application environment hosting providers

Confidential

Application Lead /Onsite Co-ordinator

Environment: Weblogic Server, Oracle 11g

Responsibilities:

• Requirement gathering and analysis and convey the same accurately to the team.
• Provides diagnosis and technical workarounds to production issues (incident resolution) and coordination with the application environment hosting providers.
• Interact with Confidential technical Infrastructure Group (Portal, Unix Admin, DBA) to resolve the issue and set up any Control M jobs
• Coordinate with offshore Project Manager and team and guide them during design, development and testing of bug fixes

Confidential

Application Supporter /Onsite Co-ordinator

Environment: ClinTrial™ 4.7, iReview, Citrix

Responsibilities:

• Provides first qualified feedback to the customer with in SLA.
• Analyze and provide solution for the above incident request.
• Responsible for 6 important category of service request including DB lock.

Confidential

Developer

Environment: Windows 2003 Server, ClinTrial™ 4.5, InForm, CIS, Oracle 9i.

Responsibilities:

• Development of forms, rules & clintrial mappings in InForm.
• Developing the BO reports based on the Data review specs.
• Designing the study book, Development of validation rules/ derivations for the study in Clintrial.
• Responsible for tracking and deliverables of all the activities for a trial from reviewing the Data requirement specifications to till study goes live.
• Understand the client’s requirements and review the trial functional specifications.
• Coordinate and communicate effectively with primary contacts at Client teams & data management team to ensure satisfactory progress of study (Including timelines) and timely resolution of issues and also track the minutes of the meeting.
• Participate in weekly/monthly defect prevention meeting with the project lead.
• Performing the role of SME in InForm with the project.
• Performing change request for a study, Includes analyzing the impact on study in InForm, Clintrial and Reports and development of the same.

Confidential

Developer

Environment: Windows 2003 Server, ClinTrial™ 4.4, Oracle 9i.

Responsibilities:

• Performing the ‘Forms - Technical review’.
• Performing the ‘Edit Check Specification for Validation - Technical review’.
• Designing the SBT for the study.
• Development of validation rules/ derivations using ClinTrial™.
• Setting up a clinical trial and performing integration testing of the developed rules.
• Performing DRL (Database amendment) for existing trial