SUMMARY

• Senior IT Executive/Technical Lead/Application Manager with 14+ years of industry experience in Enterprise Content Management and over 5 years of experience in the life sciences industry.
• 2+ years of experience as IT System Owner on FDA regulated applications.
• Development and Support experience on Veeva Clinical, QualityDocs, Promomats, MedComms and RIM Vaults.
• Development and support experience on Veeva CRM, Salesforce.com platform.
• Development and support and migration experience on EMC Documentum products
• Excellent analytical & project management skills and proven ability to work independently or in small or large teams on multiple projects at a time and deliver with quality and zero defects.
• Ability to prioritize and work on multiple implementation projects and day to day support activities.
• Veeva Vault Certified Administrator, Salesforce Certified Administrator (ADM - 201), Sun Certified Java Programmer 5, EMC Content Management Foundations (E20-120) certified, Certified on ITIL V3 Intermediate level (Service Transition Module) and ITIL V3 Foundations modules.
• Well versed working with customers/teams across various geographical locations and cultures.
• Hold a master’s degree in Information Management (MIM) and bachelor’s Degree in engineering (Electronics) from Mumbai University (India).
• Deep understanding and experience with Service Management tools like Service Now, JIRA and ITIL processes.
• Strong understanding of GAMP and 21CFR Part 11 concepts and their application on validated systems.
• Excellent adaptability and quick learning capability in mastering new tools and technologies.

TECHNICAL SKILLS

Programming Languages: Java, J2EE, SQL, APEX

Platforms: Veeva Vault (eTMF,QualityDocs,Promomats, Medcomms, RIM), Salesforce.com Service Cloud, Veeva CRM, Veeva Align, Documentum suite.

Application Server: Apache Tomcat, IBM WebSphere, WebLogic

Tools: & Utilities: Eclipse, Process Builder, Forms Builder, Samson, DQMan

Database: SQL Server, Oracle

PROFESSIONAL EXPERIENCE

Confidential

Technical Architect/Senior Business Analyst

Responsibilities:

• Principal Consultant leading application configuration, support and maintenance for Bioverativ eTMF, Promomats, Medcomms, RIM Vaults.
• Responsible for gathering & understanding business requirements, design, development, testing and support for Veeva Vault eTMF, Promomats, Medcomms, RIM implementations.
• Team member for Salesforce.com /CRM related projects such as Service Cloud, Veeva CRM and Align.
• Work directly with business owners to gather requirements for Veeva Vault and translate those business requirements into technical specifications and solution.
• Provide internal technical leadership and work with third party vendors in case of escalations.
• Participate in Computer System Validation activities for GxP applications.
• Assist with maintenance of business and technical documentation related to Projects such as SOPs and Work Instructions and assist in creating such documentation from time to time to ensure smooth running of the projects and from compliance standpoint.
• Act as Veeva Vault Subject Matter Expert in recommending fixes and enhancements to production Vaults.
• Perform Risk Impact Assessment for upcoming Veeva Vault General releases to recommend to the business new platform features.
• Co-ordinate with business and testing teams to formulate validation strategy
• Collaborate with Cross-functional and Vendor teams for integrations and governance.
• Design and create reports and dashboards in Veeva Vault and Salesforce as per the business requirement.
• Automation of manual processes like creating or updating bulk users, updating multiple sites, upload bulk documents in Veeva Vault using Loader Utility.
• Provide Cross Veeva Vault Governance support by creating best practices in area of Vault domain management, Single sign on and Change and Release Management.
• Participate in Veeva Center of Excellence team meetings to provide advisory support for various Veeva Vault initiatives and upcoming projects.

Technologies: Veeva Vault eTMF, RIM suite, Promomats, Medcomms,Salesforce.com,Veeva CRM, JSON,XML, Ideagen Pleasereview,EXTEDO eCTDManager.

Confidential

Technical Architect/Senior Business Analyst

Responsibilities:

• Veeva Vault eTMF Application is a cloud/SaaS application that has been configured to meet the requirements of the Bioverativ- Confidential .
• The Veeva Vault eTMF Application is used by R&D users that allows for management of the Trial Master File (TMF) documents by providing a repository for storing documents related to Bioverativ clinical studies.
• The system is accessible online via a web connection to both internal users as well as external CRO/study team users.
• The system currently has around 500 active both internal and external CRO’s who upload TMF specific documents and run Quality Control (QC) and Inspection Readiness (IR) workflows to ensure that the TMF is up to date and inspection ready at any time.
• The system provides enhanced reporting and dashboard functionality to TMF users so they can ensure that the TMF is always update to date and inspection ready.
• Conducted multiple face to face meetings with the eTMF business owner to understand the current issues faced by business users in terms of Veeva Vault security and data model, QC and IR workflows, document and study reporting, Expected document lists and Single sign on authentication of Veeva with OKTA.
• Created a separate case in JIRA for the above requirements, update requirement details as understood from the business in the case, requestor details, priority and approver details.
• Assist the business owner to update gathered business requirements into User requirement specifications (URS) document for the new or updated requirements.
• Update Functional requirement specification (FRS) document to reflect the corresponding requirements updated in URS.
• Discuss with the business Owner and attach risk priority to the requirements in FRS.
• Update the trace matrix document to link the requirements from URS to FRS and to the trace evidence (Test Protocol)
• Upload URS, FRS, Trace matrix to Veeva QualityDocs and send for approval to Business Owner, IT System Owner (ITSO) and IT Quality.
• Created Microsoft Visio diagrams in case of QC and IR workflows and got them validated from the business owner.
• Discuss and analyze the requirements in detail with Veeva Managed services if needed.
• Discuss timelines and estimate for the features to be implemented in Sandbox, UAT and Production environments with the business and IT system owner.
• Conducted meetings with IT Infrastructure team for activities related to OKTA single sign on configuration
• Perform risk impact assessment of Veeva general(upgrade) for 18R1,18R2,18R3,19R1,19R2 and 19R3 releases with Veeva Customer Success Manager and Managed services along with eTMF business owner.
• Attend webinars conducted by Veeva Customer success teams for eTMF (Clinical) and Platform features for upgrade release
• Attach risk and impact priority for the upgrade release features that are “auto-on” to see if there is any risk or impact to the current functionality or validated state of the system.
• Assign Change level 0,1,2 or 3 to the release features, change level 3 being of highest risk and impact and accordingly co-ordinate with Computer System Validation (CSV) team for testing strategy and update to the UAT plan.
• Perform dry run/testing of the auto-on features in Veeva Pre-Release environment to see if there is any impact to the existing business data and configuration of existing workflows, lifecycles, document types, fields and business objects.
• Discuss configurable features with the business owner, perform configuration in Pre-release Vault if requested by the business and provide walk through of the functionality.
• Performed enhancements and developed new functionality through configuration of document types, fields, document workflows, object workflows, lifecycle states, permissions, dynamic access controls, field security.
• Configured the document lifecycle security so that minor DRAFT versions cannot be hard deleted by the authors, provided for soft delete action for the business admin profile and document lifecycle state called DELETED in the configuration as an alternate functionality.
• Updated the IR Workflow functionality to add “IR Failed” lifecycle state for the document. This was required for the business to clearly identify which documents failed Inspection readiness process and how to remediate further
• Configured “IR Failed Issue Type” and “IR Failed Issue Comments” document fields in the data model that the IR Reviewer would be prompted to populate upon failing a document for IR Review workflow task.
• Added document lifecycle state “IR Review” in the configuration and set permissions in the security settings for the state for roles.
• Configured IR workflow object in the system that would set IR Review date and send tasks to the user in the IR Reviewer role for the document.
• Created Decision tasks to route the tasks and document to correct lifecycle state depending on the outcome selected by the reviewer.
• Updated field dependencies for “Inspection Readiness?” Boolean field in the configuration so that “IR Issue type” and “IR Issue Comments” are only enabled when the document has failed Inspection Readiness review.
• Created notification templates to be sent to the author/owner of the document incase of a failed IR review.
• Updated TMF Security Guide for IR Review config updates to include the changes to the user creation process.
• Created deployment plan and checklist to deploy the configuration changes to the sandbox, UAT and production environment as part of change control documentation.
• Created vpk(deployment) package file for the changes made to the document lifecycle states, document fields, permission sets, workflow and deployed the package to sandbox and higher Vault environments upon approval of change control from business, ITSO and IT Quality.
• Facilitated with IT testing/Validation team to drive the test strategy, updated UAT plan, testing scenarios, test plans for the new functionalities.
• Facilitated execution of the verification protocol for Veeva upgrade releases with the business owner to ensure that the auto-on/configured features have been verified in the pre-release environment.
• Created release verification summary report to summarize the verification cycle for the Veeva Vault upgrade release, patch, or hotfix, assuring that eTMF production vault(s) remained “fit for use”.
• Performed production support activities such as creating users (both internal Sponsor and external CRO) and adding them to Study team assignment roles (STA) and user role setup (URS) objects, user updates and deactivations.
• Worked with the TMF business owner to create user access request form templates to be used by internal and external users, streamlined user access request process in JIRA
• Automated study and study site creation manual processes using Veeva Vault Loader utility by creating a loader template easily customizable for bulk creation purpose.
• Automated manual user creation process where multiple users were being requested using Veeva Vault Loader utility.
• Created reports and dashboard metrics for QC (#pass/#total) by CRO company for the TMF business owner to compare quality review of each set of users/companies to each other
• Created monthly flash report in Veeva of active plus inactive users in eTMF vault with roles and send email to TMF business owner on weekly basis.
• Created reports and dashboard metrics for the business Owner to report all pending QC and IR reviews for more than 15 calendar days from document upload sorted by company and by Workflow name (QC or IR Review)
• Created eTMF System Administration SOP and WI documents to contribute to Veeva eTMF Vault administration activities in the area of user and groups management, study management, study site management.
• Report the usage of active and archived study site licenses to ITSO for demand planning,co-ordinate with Veeva Account Manager and ensure that purchased licenses have been successfully applied to the system.
• Manage Veeva upgrade release announcement to the end users (internal and external) by communicating the downtime and provide information of the new features being released.
• Troubleshoot production incidents related to workflow, study assignments, reporting, QC & IR workflows, TMF Viewer component, picklist values not showing up, documents not being visible due to “Blinding” field not being set and provide resolution to the user via JIRA ticket.
• Update the doctype configuration for type, subtype and classification, department details via approved change control to reflect the current TMF management plan.
• Updated eTMF Business administrator custom security profile so all Reports and Dashboards created in the system are editable by the users in the profile.
• Worked on multiple data migration projects to upload multiple study documents from the range of 1500 to 5000 documents using Vault loader utility, assisted with creation of data migration plan, test scripts to validate the migration.
• Updated document data model at the base document level so that all inheriting subtypes and classifications include “Company” mandatory field upon document creation, existed existing documents Company field with appropriate values as received from the business owner using Vault Loader utility.
• Co-ordinated migration of Study Team Assignment to Person data model changes with Veeva Managed services, updated eTMF security guide for the changes in the user management process updated FRS, Trace matrix, validation documents to reflect the changes to the data model due to this change.
• Created test users in eTMF sandbox and Validation environments for all security profiles, maintained the test users log in PMO Vault and shared with the team members.

Confidential

Technical Architect/Senior Business Analyst

Responsibilities:

• Participated in requirements gathering meetings with Veeva Professional services team along with RIM business owner and Bioverativ Project Manager, provided technical inputs on design of QC, Approval workflow, dynamic access control (DAC) security for documents.
• Conducted meetings with Regulatory Operations team to gather the requirement to fix the dynamic access control (DAC) security of the submission documents (Clinical, Non-Clinical, Quality, Safety-PVG doctypes) for the Editor role.
• Documented the change requests in JIRA for the config changes to be made.
• Updated the Functional requirement specification (FRS) document for the RIM Vault.
• Discuss with the business Owner and Project Manager and attach risk priority to the new/updated requirements in the FRS document.
• Updated the trace matrix document to link the requirements from URS to FRS and to the trace evidence (Test Protocol)
• Upload the FRS, Trace matrix to Veeva QualityDocs and send for approval to Business Owner, IT System Owner (ITSO) and IT Quality.
• Discussed and estimated timelines for implementation in sandbox, UAT and Production environments with business owner and ITSO.
• Performed risk impact assessment of Veeva general(upgrade) for 18R2,19R1,19R2 and 19R3 releases for RIM Vault.
• Attended webinars conducted by Veeva Customer success for RIM suite and Platform features for the upgrade release.
• Attached risk and impact priority for the upgrade release features that are “auto-on” to see if there is any risk or impact to the current functionality or validated state of the system.
• Assigned Change level 0,1,2 or 3 to the release features, change level 3 being of highest risk and impact and accordingly co-ordinate with Computer System Validation (CSV) team for testing strategy and update to the UAT plan.
• Performed dry run/testing of the auto-on features in Veeva Pre-Release environment to see if there is any impact to the existing business data and configuration of existing workflows, lifecycles, document types, fields and business objects.
• Discussed configurable features with the business owner, perform configuration in Pre-release Vault if requested by the business and provide walk through of the functionality
• Performed configuration of the implementation release in Sandbox and upgrade release in Pre-release environments.
• Updated document lifecycle state security settings in the configuration for the Editor, Owner, Business Admin roles to meet the business requirements.
• Configured security of “Safety Reports” documents by creating a new doctype group for safety reports so these documents are only visible to the users in Reg Ops group.
• Configured security of Submission documents (Clinical, Non-Clin, Quality, Regulatory) by creating “General” doctype group so these documents are visible to the general users.
• Updated all the security profiles to remove “delete” privilege on “all objects” for “all roles” (contributors, consumers, etc.) except for Business Admin profile in the configuration as an emergency change request for the requirement missed during initial implementation of the system.
• Created deployment package file (.vpk) to include all configuration changes and deployed them in higher environments after changes had tested by the business and approved by the business owner, ITSO and Quality.
• Periodically reviewed and updated RIM Vault security guide if needed to reflect the current user, group, dynamic access control roles in the system
• Troubleshoot production incidents related to running workflows, document security, Submissions Archive Viewer, Applications, Activities, Submissions, Registrations objects and educated end user on product usage and how to avoid the same in the future.
• Automated manual user creation process of creating multiple user role setup objects for a single user by designing a generic loader template.
• Interacted with business owner and Veeva product management team to suggest ideas to enhance Submissions Archive Viewer component in the platform.
• Co-ordinated with Bioverativ to Confidential RIM Platform migration team to perform configuration of the submissions and archive modules to Read-Only on the migration Go-live.
• Co-ordinated with the “Preserve” archiving team at Confidential to bulk extract Submission archive applications and Submission documents to be archived in the future.
• Co-ordinated with business owner and ITSO to plan for licenses by reporting on current active users and deactivating the users who have been inactive per RIM admin SOP guide.
• Co-ordinated with the business users via JIRA ticketing tool to create custom reports related to Products, Applications, Regulatory Objectives, Activities or other custom and related objects.
• Co-ordinated with business owner to configure the security settings of all doctypes for new document and binder creation, page layouts to add additional fields for custom objects, notification templates for Approval and Authoring workflows.