SUMMARY:

• Business Project Management professional with 18 years of experience providing solutions to support strategic business objectives with specialty in IT, infrastructure management, quality management, software application life cycle, new product development and process improvement.
• Strong knowledge of Clinical and Regulatory operations including clinical trials, pharmacovigilance, new drug submissions, clinical project management and clinical trials registry.
• A change agent and strategic thinker Confidential makes a difference through accountability, process improvement, communication, and attention to details.

EXPERTISE AREA:

• Global Service Delivery & Operations Management
• Data/Business/Systems Analysis
• Product and application life cycle management
• Data integration and custom reports
• Quality Management and process improvement initiatives
• Teaching, mentoring, and coaching
• Data Flow & Process Mapping
• Stakeholders, Risks & Issues Management

BUSINESS &TECHNICAL SKILLS:

PM Tools: Microsoft Office Suite, MS Project Server, JIRA, Confluence, VersionOne, Basecamp, Open Project, Clarizen, Rational Project Conductor, Clearview’s InFocus, Visio, HP Quality Center, SharePoint, Documentum

Frameworks: Agile(Scrum), SDLC (Waterfall), PMBOK, Microsoft Solutions Framework, Sprint Planning & Execution

Technical Skills: JDBC, Hibernate, Oracle, MySQL, Sybase, MS SQL Server, Cloud, Hybrid Cloud, UML, Data Flow

Software Products: SiteMinder, ARISg®, Argus®, EDC solution (TrialMaster, eClinical Data Entry), JReview, MediData Rave, Seibel, Informatica, Cognos, BI

Business Skills: 21 CFR Part 11 guidelines, E2B R3, HL7, IDMP, ICH guidelines, Regulatory submission requirements, Good Clinical Practices, GxP, GMP, CAPA, CSV, CDISC, CDASH, SDTM, ADaM, EVMPD, IDMP, eCTD, Drug Development Process, eCOA, ArisGlobal on Total Safety Suite, Argus® Safety knowledge, Confidential Regulatory suite of regulatory information management (RIMS)

PROFESSIONAL EXPERIENCE:

Confidential

Senior Project Manager

Responsibilities:

• Drove major projects, programs, and initiatives from planning through tactical execution, as well as mastered advanced methodologies, processes, and technologies
• Drove technology projects, serving a link between business users and developers to ensure delivery of new solutions according to client requirements
• In charge of program, schedule, finance, and overall team management on large client - based implementations of hosted platform of agOnDemand(SaaS) and on-premises solutions
• Allocated local and global resources in accordance with strategic and tactical priorities and company goals and objectives
• Worked closely with clients and business stakeholders to assure alignment between business objectives and engagement goals
• Effectively managed a diverse group of globally dispersed team members from the business, IT and external service providers
• Designed, coached and implemented custom processes and methodologies
• Possess clinical, safety and regulatory domain knowledge so as to understand client’s marketplace, competitive landscape and business drivers
• R&D systems - Discovery, Pre-Clinical, Clinical Development, Regulatory requirements and submissions, QA
• Developed business cases and streamlined procedural documents in accordance with functional needs and the client's expectations, while gaining consensus at the executive level
• Developed Key Performance Indicators (KPIs) to monitor client-specific operations, while ensuring timely attainment of Service Level Targets (SLA) with highest Customer Satisfaction (CSAT)
• Implemented and monitors best-practice metrics and streamlined QA to increase efficiency and maximize resources, which resulted in 100% client loyalty in competitive tech industry
• Project management - status reporting, milestones, Risk and issue management, change control, resource conflicts, effective communications, and stakeholder management
• Project planning - project charter, WBS schedule, critical path, resources, budgets, risks register and other deliverables
• Software validation(CSV) - Validation approach and Test Strategy, validation plans, developed Traceability Matrix, developed and executed Validation Scripts, Issue Management and prepared Validation Summary Report (IQ, OQ, PQ, UAT, vendor audit, business partner assessment, information security practices)
• Vendor management - manage on-site and off-shore resource teams, develop RFP / SOW for vendor services, implementation and management of SaaS hosted applications
• Data integration from SAP/Oracle ERP to clinical, Regulatory and drug safety systems
• Enterprise integration with Active Directory, emails and E2B Gateway
• Integration of IRT system with Oracle Argus safety system
• Data Migration from legacy systems to ARISg
• Custom report developments using Cognos, BI tools

Confidential

Sr. Software Engineer -Lead

Responsibilities:

• Helped introduce a new, reproducible project implementation methodology that contributed to higher-quality product releases and a 23% reduction in errors
• Championed the implementation of coding reviews that detected programming errors for edit checks early in the development process, accelerating product go-to-market time by more than 15%
• Liaised and integrated clinical software application with other shared services (Single Sign on, Site Minder, LDAP, external applications, SDTM, patient diary, IVRS, ePRO) and evolving standards from organizations such as FDA, EMA, CDISC, ICH, and HL7
• Performed cost-benefit and feasibility analyses to determine whether requirements are best met by manual, software, or hardware functions or by making maximum use of commercial off-the-shelf or already developed components
• Coordinated with other clinical operations personnel to ensure the timely and quality preparation of project
• Planned, implemented, and coordinated clinical data management activities supporting Phase I-IV clinical trials from study set-up to study lock, using a double data entry (paper method) or EDC study (electronic method)
• Developed Data Management Plan (DMP), and maintained DMP throughout lifecycle of study project, while ensuring DMP is followed according to study design and requirements
• Performed review of clinical research documents (ex: protocols, case report forms, reports and statistical analysis)
• Built and deployed trial for different customers, by using an incremental approach, resulting in improved quality, and the opportunity to leverage experience and knowledge of industry best practices
• Developed database clinical trial data specifications, including eCRF design, user requirements, even schedule, patient randomization, edit rules/checks, derivations, query logic, workflow (study, monitor and query) and data validations (hard and soft)
• Reconciled electronic data transfers from vendor to sponsor develop test scripts and execution logs for User Acceptance Testing (UAT)
• Coordinated UAT of eCRF build and validation documents, edited check document, issue logs, and UAT summary report
• Maintained EDC user management and other clinical databases across allocated clinical trials, including but not limited to, compiling master user lists and activating/deactivating user accounts
• Ensured clinical data within EDC is in quality to lock/unlock and freeze/unfreeze, as appropriate for statistical analysis
• Assisted in defining and/or creating data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit
• Performed MedDRA and/or Confidential coding
• Assisted in reconciling AE/SAE data in Safety DB and/or other Data Management DB
• Coordinated and communicated with IT and DB team on consistent basis to address clinical team’s requests, project plans, and/or eCRF development activities
• Ensured data system compliance by following the established guidelines of national and international regulatory authorities