SUMMARY:

• Superior Decision Making and Consultancy Management Professional with 25-years plus track record on IT operated domestic and international contract workload Programs/Project Management and assignments on Pharmaceutical Industry, Contract Research Organizations, CROs and Managed Healthcare Organizational Plans, HMO , Business Intelligence, Financial and Business Analysis, and Clinical Data Management and Drug Safety Surveillance Specializations. Over 15 years plus of experience as Project Manager/ Sr. Business Analyst in IT industry with excellent Understanding of various phases of Software Development Life Cycle SDLC . Authored and created PSURs ensured that Clinical Data Management Plans and Drug Safety Technical Reports are FDA 21 CFR Part 11 compliant in accordance with standards, processes, and procedures.
• I possess comprehensive knowledge and practical hands on know how experience and skills with product and services process research and development, on processing laboratory techniques, data management, documentation, quality assurance, and regulatory requirements as per FDA and ICH regulations on pharmaceutics Phases II-IV After Market including diseases, medication and/ or food science.
• Excellent knowledge of Human Resources Management and Regulations, Financial Accounting and US GAAP system for analyzing financial statements of income statement, cash flow statement and balance sheet and preparing the financial indicators Growth Ratios, Liquidity Ratios Operating Efficiency Ratios, Leverage Ratios and Cash Coverage Ratio.
• Possess over 15 plus years of broad experience in diversified technical and leadership areas with increasing senior level managerial of project management up to directorship responsibilities. Experienced in high performance consensus team building by initiating, implementing and maintaining effective work relationships with both local and culturally diversified international staff members.
• Demonstrated and exhibited understanding of Data and Drug Safety Project Management standard and advanced techniques
• Led, managed, monitored and implemented drug safety project management techniques that achieved and went over and above the desired goals applying strong project management pillars.
• 15 years plus of experience as Project Manager/ Sr. Business Analyst in IT industry with excellent Understanding of various phases of software Development life Cycle SDLC .
• Experienced in documenting business process analysis research, JAD sessions, requirements gathering, gap analysis, and step-by step user manuals preparation and functional specification design,
• Skilled in Banking/Finance domain/products including Accounting Principle, Commercial Loans, Mortgage and Prepaid-Card Business.
• Experience in Use Case Realization, Activity Diagrams and Sequence Diagrams using UML Modeling and writing use cases in RUP Methodology with MS Visio and Rational Rose.
• Strong analytical problem identification, problem-solving and communication skills, with emphasis on clear, detailed Business Requirements with SAP Security knowledge.
• Proficient in Risk Management planning, which includes Risk Identification, Assessment, Risk Analysis, Reporting, and Risk response/monitor/ control.
• Experience in User Acceptance Testing UAT process.
• Experienced and skilled Diplomacy and International Relations expert on conflict resolution and negotiation management on one hand and Global Health, Human Safety and Security Administration on the other areas of expertise. An advent International Business and Trade novice earned from Wall Street gurus.
• Deep knowledge of understanding and vast professional experience in the United Nations System and its branches working platforms, namely General Assembly, the Security Council, the Economic and Social Council, the Secretariat, the Trusteeship Council , and other organs of the larger United Nations family encompassing of its fifteen, 15 Agencies and Several Programmes, and other branches including the six, 6 Committee Meetings technical Advisory and Procedures.
• Deep and excellent understanding of gathering and documenting functional State of NJ Division of Developmental Disabilities DDD and the State of NY departmental government functionalities.
• Mission that assures individuals with developmental disabilities the opportunity to receive quality services and supports by participating in meaningful life improving activities in their communities and exercise their right to make right choices befitting their capacities.
• Posses excellent care giving abilities to individuals with developmental disabilities who live daily with intellectual disabilities, cerebral palsy, autism, epilepsy, spina bifida, traumatic brain injuries and certain neurological impairments among others.
• Experienced in high performance consensus and team building by initiating, implementing and maintaining effective work relationships within culturally diversified working associates within the service delivery towards individuals with developmental disabilities.

PROFESSIONAL WORK HISTORY

Confidential

Responsibilities and Achievements:

• Successfully took charge of major responsible areas but not limited to quality environmental safety changes impacted on existing system functionalities. Was responsible for new complex process analysis, design, monitoring, simulation and process re-engineering improvement evaluation levels. Successfully capacity building methodology in interacting with end-user customers in making them understand the prototype, functionality specification development, data mapping, setting of configuration tables, documenting configuration and end-user procedures' requirements, and conducted effective end-users' training. Functions as a project manager or functional lead on large to mid-size projects. Responsible for the entire lifecycle of a project. Manages project team resources to successfully meet the project objectives in terms of functionality, time and cost.
• Successfully followed standard project methodology on works approved, prioritized projects and enhancements, following existing change management and project management procedures.
• Completed assigned projects in an accurate, timely and prioritized basis through periodic status reports detailing the progress of all on-going projects by accurately laying out scopes out length and handling difficulty of tasks and schedules work accordingly.
• Coordinated work as required through workers' motivation applying available resources that met project objectives by developed and managed segment of the project plan.
• Performed, configured and developed program specifications required that met the project objectives. Identified potential issues, which could impede business requirements delivery, brought them the attention of the functional team leaders and/or project sponsors through consensus resolution and obtained desired business results.
• Applied extensive experience and skills in implementing systems in the Quality, Safety, R D or Environmental space using wide knowledge of Microsoft Technologies, grasp of diversified Project Management programming languages, MS Projects and SAP modules, Quality Management, Safety, Environmental and Sustainability processes with demonstrated analytical and problem-solving skills and use of ability of handling multiple priorities and deadlines.
• Performed financial allocations monitoring and expenditure ceilings.
• Successfully prepared financial reports on programs and projects expenditures produced analytical reports based on current and past expenditure trends
• Made foreseeable recommendations on expenditure rates and provided timely alert on possible benchmark areas.
• Advised accordingly decision making authorities thru duly prepared analyses on use of core funds allocations and expenditures trends. Applied FAASB and organizational financial rules and regulations
• Closely monitored the Operating Fund Accounts status and proposed next cause of action for the timely clearance of expenditures.
• Maintained and updated all organizational related programs and projects database through implementation of financial status and regularly coordinated with MIS and Finance Departmental quality and timeliness of reports. Actively participated in the financial statements' preparations.
• Provided professional assistance in liabilities and balance sheet statements preparation in relations to available reports and the related working papers.
• Provided acceptable audit recommendations and follow up on financial expenditure updates from the database in compliance with all administrative and financial requirements.
• Skillfully researched and drafted responses to inquiries received and performed over and above scope of required duties.

Confidential

Relief Manager

Responsibilities and Achievements:

• Tasked with and successfully handled, managed and administered multiple Projects and service operations delivery assigned managing over 15 plus direct employees.
• Developed and maintained project Daily Log Plans, coordinated Medical Access Records, MARs , and other activities tracked milestones and ensured that end-to-end project planning, risk identification, dependency tracking, issues identification and escalation then applied change management appropriately utilizing PM best practices.
• Developed and maintained expertise and knowledge of all assigned project assignments and adhered to applicable Caring, Inc. Corporate Guidelines, Standard Operating Procedures, DDD of the New Jersey's rules and regulations on overview operations, Abuse and Neglect, Medical Certification and Dispensation among other Medical Regulatory, Drug Safety and Clinical Data Management acceptable practices.

Confidential

Responsibilities and Achievements:

• Tasked with and successfully directed, advised, handled and executed International and Domestic Healthcare Investment Business Finance Data Management Accounts that realized millions of dollars in business profits on Clients Global and national Programs/Projects cadre.
• Diligently performed People Development Performance role of counseling and coaching by providing input and guidance into the staffing process actively participated in staff recruitment process, training and retention activities and provided stand up leadership and support for delivery teams and staff within and under my direct and/or indirect report.

Confidential

Responsibilities and Achievements:

Applied basic and advanced gained qualifications and experience performed the duties assigned and beyond applying my technological and management proficiency in ETL technological workforce platform tools including diversified software such as Informatica, Data stage, SAS and other software administration, one or more of major BI Reporting tools such as Business Objects, Hyperion, Cognos, SAS and their administration, major metadata tools and their administration, one or more of major OLAP tools such as Micro Strategy, Hyperion, Brio, SAS and their administration, and one or more of major data modeling tools such as Erwin, Data Architect, Oracle Designer and their administration. Is able, ready and willing to show the ability to work independently and/or successfully have managed multiple task assignments using strong oral and written communication skills, including presentation skills of MS Visio, MS PowerPoint among others.

Confidential

Responsibilities and Achievements:

• Successfully handled and achieved Phases III, IV and After Market Products Anti-Effective, Oncology, and Immunology, Cardiovascular, and CNS Central Nervous Systems Studies requirements. Skilled and efficient on Rational Rose, Rational Requisite Pro, MS SQL Server 2000, MS Project, SAP, MS Excel and MS PowerPoint, ASP. Net and Windows 2003 Institutionalized Home-grown Software such as Merck CO's World Clinical Data Management Organization Continuous Tacking System WCDMO's - CTS , Schering Plough Drug Safety Department's CAVIAR and J J DLB Recorder Skills and experience, EDC, ARGUS Drug Safety, Pharmacovigilance, OTC and ARISg Applications Information Systems experience environments. Harmoniously created and processed cases using home grown computerized Adverse Events information, reporting analysis CAVIAR 6.0 and 7.0 Systems. Compiled reports and copied cases, made correspondences, and distributed case and table reports. Tracked cases by production, organization, communication, maintenance, and case file systems. Prepared initial entry of Adverse Events reports in the drug safety and surveillance database. Managed project plans, project execution, and desired project's goal achievement while maintaining program/project needs and outcome across multifaceted technical and professional departmental input/output requirements.
• Reviewed, modified, and summarized reports and records during program/projects progress, controlled budgeted expenditures in accordance with budget allocations and redirected program/projects activities and attained objectives desired by preparing summarized and detailed project/program reports for superiors' decision making.
• Created, revised, reviewed and maintained operating procedures that supported Clinical Data Management Plans and Drug Safety Periodic Safety Updates Reports', PSURs efficiency and cost effectiveness. Authored and created procedures and ensured that Clinical Data Management Plans and Drug Safety Technical Reports are FDA 21 CFR Part 11 compliant with standards, processes, and procedures. Performed Quality Review and Assurance that improved Drug Safety Data Management Plans, Technical Reports and Standards. Performed, supported, maintained and developed Clinical Data Management Plans and Drug Safety and Surveillance Corrective Action on Special Project assignments. Participated in finding conflict root cause report, reviewed and recommended corrective actions for improvement. Assessed Adverse Events Reports, created queries, performed edit checks, pursued and resolved drug safety quality control discrepancies of the required information in the reports. Reviewed AEs and SAEs and acted according to FDA 21 CFR Part 11 compliant, European, other global regulatory authorities and ICH procedures.

Confidential

Responsibilities and Achievements:

• Tasked with and successfully handled and completed Phases III and IV Cardiovascular, Infectious Diseases, Oncology and Hematology studies cases applying MS Project, SQL, ASP, Oracle, Test Director environments and created queries, performed edit checks, and resolved discrepancies. Reviewed participants enrolled in a protocol. Reviewed CRF data and performed error resolution, quality
• control, and validation procedures via programmatic and/or manual methods. As a Professional and technologically savvy I applied clinical judgment on discrepancies in entered data databases.
• Successfully utilized reports to track discrepancies in CRFs and sent out thorough DCFs for clarification. Generated, sent and resolved DCFs. Participated in the development of Clinical Data Management Operating Procedures Standards. Revised DMP's to meet study specifications. Ensured the Oracle Clinical database confirmed with study plans. Complied with organization's standard operating procedures SOP's and performed tasks assigned as instructed by superiors. Was responsible for support project teams with researching, resolving and documenting data discrepancies.

Confidential

Responsibilities and Achievements:

• Tasked with Phases III and IV Cardiovascular, CNS Central Nervous Systems and Neurology and Diabetes Type II Studies
• Involved in the design of the Oracle Clinical 8.0 database and verified accuracy of patient modules in accordance with protocol inclusion and exclusion criteria. Performed continuous per patient/visit review of clinical trial data through manual and automated methods for the purposes of ensuring overall data integrity and consistency. Authored and categorized data discrepancies and applied data changes resulting from discrepancies. Interacted directly with investigative sites for the purpose of resolving data discrepancies and providing data quality feedback. Worked with vendors and contracting CROs to resolve data quality issues.
• Ensured Oracle Clinical Database confirms with study plans. Performed the duties of applying applicable Clinical Research proven IT Applications databases such as MS Word, MS Excel, and Oracle Clinical and Clintrial software. Acquired and gained knowledge of MRL Clinical Research WCDMO CTS Data Management System Applications for Data Review using Queries Patient Viewer and for Continuous Data Review. Supported re-mapping of terminology in the clinical trial system due to vocabulary updates.

Confidential

Responsibilities and Achievements:

• Tasked with Neurology, Pharmacology, and Toxicology Studies Handled clinical data entry from CRF for completeness, logic, adherence to protocols basics and ensuring standards were met, from study start up to finalizing database. Skilled in Clinical Trials Procedures, FDA, GCPs, ICH applicable regulations and guidelines and ensured that the data collection process was in adherence to company SOPs. Maintained and updated clinical data processing conventions, SOPs, and met project timelines.
• Managed clinical research data for the new and ongoing electronic clinical trials. Coding experience with the following medical dictionaries, MedDRA and WhoDrug , and WHOart. Worked with sponsors to resolve CROs data quality issues and communicated data collection issues, data inconsistencies and laboratory issues with sites and lab vendors. Designed and revised Oracle Clinical 4.0 database modules and developed, established and implemented SOP friendly Data Management Plan DMP .

Confidential

Responsibilities and Achievements:

• Managed and Protected human safety and client company assets applying developed and integrated loss prevention strategies. Identified potential security breaches in and sealed the loopholes. Apprehended, prosecuted internal and external client property
• pilferage and unwanted losses. Apprehended intruders on corporate facilities, and maintained loss prevention awareness focusing on the USA Security Associates, Inc and Client Company's mission, vision, goals and security and safety standard operating procedure manuals. Oversaw Loss Prevention operations of the specific sites assigned and reported and advised with Regional Safety, Security and Loss Prevention Management matters to Sr. Safety, Security and Loss Prevention Field and corporate Directors that produced safe and secure environment to clients and their clienteles' chain.
• Supervised a workforce of twelve direct employees reporting to me. Compiled, managed employees' schedules and on client site employees' payroll returns. Interviewed applicants, hired, trained newly hired employees and fired non-performing employees. Made timely and financially acceptable proposals to the company's Employees' and Machine's budget. Conducted yearly Appraisals and recommended raises and promotions to employees under my direct supervision. Oversaw closing Plant's equipments transfer adhering to safety and environmental laws and no monetary loss incurred. Received a three-year Certificate of Supervisory Continuous Service Award.