Systems Validation / Project Manager / Clinical Systems Analyst
Resume:
Frank Twumasi
** ********** **., ********, **.
******@*****.***
Professional Goal & Profile
I have demonstrated the ability to think and plan strategically, provide leadership in a changing and dynamic environment and interact skillfully with senior management. I have impressive international work experience (Ghana, UK, US, Germany, France and Norway) in operations.
My interest is in consultant positions in Systems Validation and Operations.
Education & Achievement
Masters of International Management (MIM): UMUC, MD. April 2005
Masters of Business Administration (MBA): UMUC, MD. April, 2004
Graduate Toxicology Program (Incomplete): Rutgers University, NJ, 1998
Counseling Certificate: City University of London, July 1994
Biochemistry (BS): University of Science and Technology, Ghana, June 1992
GE Business Development Courses
Six Sigma Green Belt Certified
18 Week GE Lean Training
Project Management at GE
Phase Review Discipline Overview
eNew Product Introduction (eNPI) Overview
eNew Product Introduction (eNPI) Advanced
IM eNPI Project Leader Training
MT2: Overview of The NPI Marketing Toolkit Course
MT1: Welcome to NPI Marketing Toolkit Course
Other Professional Training
A Six Sigma Approach to Achieving Project Management Quality Oct 2005
Enabling Clinical Research and Business in the Pharma Industry, Oct 2002
Cost Management conference for clinical trials, September 2002
Advanced Oracle TMS training: Bristol-Myers Squibb, Dec 2001
SAS Programming II: Manipulation of Data with Data Step, SAS Institute, Apr 2001
Advanced Oracle Clinical Training, CSS, Mar 2001
Oracle Thesaurus Management System, Oracle Corp, Nov 1999
Certified Oracle Database Administrator, Tekmetrics ID # 21522, May 1999
Databases & Systems
Oracle Database, MS-Access, Oracle Clinical /TMS, Clintrial, HP Chemstation, Ultra Edit 3.2, SQL*Plus, SAS and HTML
Work Experience
Nov 2009 - Jan 2012 Management Consultant/ University Lecturer.
Selected and trained as a consultant to the ILO Sustaining Competitive and Responsible Enterprises (SCORE) program to improve organization productivity in Ghana. This program sponsored by the Swiss State and managed by ILO. I have worked with and trained employees of 3 companies in Quality Management, Productivity and Cleaner workplace, workplace cooperation and motivating employees for productivity. The program has been successfully used in India and China to improve productivity, quality and workplace cooperation.
I was a teaching consultant at the University of Applied Management in Accra where I lecture in Technology Management, Health care Risk Management, International Health Care Systems, Hospital Management, International Business Relations and Performance in Organizations. I have developed materials and trained some private organizations and Government Agencies in Lean Six Sigma and Business Ethics.
Jan 2009 – Nov 2009,Project Management consultant, SocketWorks Ltd. Tema. Ghana
Consulted as the senior bid development strategist on SocketWorks bid for the eGhana project for the design, build, operate and transfer PPP egovernment applications for revenue generating and registrar’s generals department. I coordinated, collated and analyzed data from Motorola, Oracle, Bull, KPMG and other members of the consortium to ensure bid requirements are met in terms of software, hardware and process development methodologies.
Oct 2007 – Dec 2008, Healthcare Business Manager, GECAD Ltd. Accra (Distributors of GE Healthcare Equipment)
I was responsible for the development of strategies and execution plans from corporate goals for the business. As representative of GE Healthcare, I managed the marketing, sales, installation and servicing of Medical Equipments including MRI,s CT Scan and Fluoroscopy equipment, baby monitors’ and ultrasound systems. This involved the use of Lean Six Sigma methodologies to ensure the metrics are developed and used to track attainment of department goals. I employed and managed 4 medical sales and marketing personnel, 3 technicians and 1 IT personnel to attain department goals. I was responsible for the financial management of the business.
I selected and worked with another company to develop a document management plan for the business. I developed an IT security policy and the implemented a document management system for the company.
Mar 2002 – July 2007, Global Clinical Systems Operations Manager, GE Healthcare, Princeton, NJ.
I was responsible for providing long-term strategic operational direction by developing and implementing new processes, procedures and training in all areas of our $20 million Clinical Systems Program. Developed Project Management Plans, Scope Statements, WBS to track timelines, monitor finances and project quality with GE project management and LSS tools. I manage external consultants, vendors, and global trainers.
I was the program manager and Lean Six Sigma expert on GE Healthcare EDC implementation team. I was responsible for vendor selection and management. I worked with Phase Forward to implement trial specific Electronic Data Capture (EDC) system including edit checks, custom reports and data extracts, User Acceptance Testing (UAT), system release and system user training.
I ensured process efficiency as the Team Leader of the Oracle Clinical (OC) system validation team. I did vendor management, definition of efforts and resources (financial, personnel and time) to meet program plans. I identify critical operational issues that impact the quality of the clinical System program and implement corrective actions that are agreed on by management. I developed Service Schedule regarding shared expectations for services, the Business Decision Group (BDG) Charter, developed Validation master plan, helped in the design specification document
I lead a team to write OC validation documents, this included but not limited to documents for Sandbox testing and auditing, Operational Qualification (OQ), Performance Qualification (PQ) User Requirements Specification (URS). I developed testing cases and did the validation testing. I also developed training materials and trained user in new system functionalities in OC and TMS. I saved $2.5 Million in the upgrade and validation of clinical systems through effective employee and vendor management.
As a Global Clinical Systems Administrator, I was responsible for the management of Operational Managers and user located in Germany (10 Users), Norway (10 Users), United Kingdom (5 users) and Princeton (12 Users). I managed interaction between IT, Project managers, systems users and upper management for efficient operations. I was responsible for the daily upkeep of the Oracle Clinical database operations. I reviewed and revised Standard Operating Procedures (SOP’s) to ensure applicability to business processes as a member of the Clinical Business Decision Group (BDG). Trained users in building clinical trial databases, edit checks, data loading and extraction techniques. I made sure that our systems were CFR Part 11 compliant
Aug 2001 – Mar 2002, Senior Consultant, Bristol-Myers Squibb (BMS), Hopewell, NJ
Responsible for the successful Oracle TMS implementation at BMS clinical informatics. Built dictionary structures, level and level relations in TMS GUI in oracle clinical 3.2.0 and 4.1.3 and TMS 4.0.4. Successfully loaded and tested medical dictionaries COSTART, MedDRA, AHFS, ICDA9 and WHODRUG. Built clinical trial database, developed scripts to migrate Verbatim terms from instances in BMS south to BMS north in oracle clinical 3.2 and 4.0. Extracted clinical trial data by developing SQL*PLUS programs, using MS Access and Excel.
Sep 2000 – Aug 2001, Senior Programmer, Ingenix Pharmaceuticals, Basking Ridge, NJ.
Responsible for the technical aspect of Data management requirements for clinical trial systems. Built clinical database, wrote and tested database edit checks to create and resolve data discrepancies. Used SAS to manipulate data sets to produce data listings according to client specifications and for coding COSTART and WHO dictionary for coding of adverse events and concomitant medication. Batch loaded laboratory data, Froze, Locked clinical database and transferred SAS data set to clients in a password protected zip format. Administered and maintaining privileges system user privileges. Interacted with data managers, coders, data entry personnel and client reps to produce quality database and data.
Feb 2000 – Sep 2000, Programmer Analyst, Quintiles, Kansas City, MO.
Designed and built databases in Oracle Clinical 3.1 from Clients annotated CRF. This included setting of DVG’s, Question groups, DCM’s, editing data entry screens and moving it to production. Reviewed and wrote edit scripts used in Oracle clinical data validation. Programmed edit checks and run it against clinical trial data to generate discrepancies. Run Oracle Clinical data extract views in SAS 6.12, manipulated and printed clinical trial data according to client specification.
Aug 99 - Feb 2000, Snr Database Specialist, Phoenix Life Sciences, Blue Bell, PA.
Responsible for the company wide implementation of TMS 1.0. Designed and developed dictionary structures for WHO, MedDRA and Costart dictionaries. Developed structures for the integration of TMS and Oracle Clinical. Managed the loading of clinical dictionaries into training environment. Participated in the validation and conformance testing of Oracle Clinical for Y2K Compliance. Built databases and used SAS to query Oracle databases for clinical data.
Mar 99 – Aug 99, Oracle DBA, J J Forbes Research Systems, Elizabeth, NJ
Installed Oracle RDBMS 7.3.4 on HP-UNIX, Windows NT Servers. Designed Oracle database, created tables, views and Data management. Resizing Oracle Database, Migrated Oracle 7.3.4 to Oracle 8. Performed weekly backups.
Apr 96 – Mar 99, Associate Scientist, Merck & Company Inc., Rahway, NJ.
Supervised separation activities in the pilot plant using HPLC (Dorr Oliver) for the production of cGMP drug intermediate. Developed laboratory scale analytical techniques for the separation, crystallization and quantification of new drug candidates. Researched and improved mobile phase and raw material load used in GMP isolation processes. Prepared Batch sheets and appropriate documentation for cGMP pilot plant and preparative scale Runs. Separated and concentrated GMP materials with ultra and nanofiltration techniques. Utilized HPLC, low pressure LC, TLC and GC in the identification and quantification of GMP drug Candidates and Analogs. Ordered required equipment and lab supplies.
Aug 95- Mar 96 Research Assist, Howard University Hospital, Washington, DC
Analyzed blood samples for Sickle Cell trait using Cellulose Acetate Electrophoresis. Separated and purified hemoglobin by Gel Permeation Chromatography.
Feb 93 - Jul 95 Medical Research Assistant, G Marsh Sickle Cell Center, UK
Participated in clinical trials of Hydroxy-Urea, follow-up and counseled patients. Collected and analyzed the effect of given drugs on patients based on the parameters like packed cell volume and the amount of Fetal hemoglobin. Induced sickling in RBC in-vitro and electrophoretic analysis of hemoglobin to determine various hemoglobinopathies, (e.g. HBs, HBc and Thalassemia). Ordered supplies and Maintained lab records.
Publications
Stanik, M; Twumasi, F; Yamazaki, S; Goklen, K. (Merck) Biodeacylation of Pneumoncandins: Application of Ultra filtration and Nanofiltration for scale-up process. Presented at American Chemical Society, Boston, August 1998.
Global Exposure
Worked in the UK, Germany, France and Netherlands Norway and Ghana. Manage and interact daily with multi-disciplinary international teams.
Memberships
National Black MBA Association (NBMBAA)
GE African American Forum
International Society of Six Sigma Professionals (ISSSP)
American Management Association (AMA)
Drug Information Association (DIA)
Project Management Institute (PMI)
University of Maryland University College Alumni
Oracle Clinical User group (TMS Focus group)
University of Science and Technology Alumni
Opoku Ware School Alumni
Exceptional Letters of Recommendation upon Request
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