QA Analyst/ engineer

Alfred A.M. Yarjah (B.Sc., MCSE, MCDBA)

***** ********* ***., ***. *** Tel: 301-***-****

Silver Spring, MD 20906 mailto:*******@*****.***

SUMMARY

I presently work as a Data Management Associate (an Oracle Clinical Database Developer) with 8 years experience in working with Oracle Clinical Databases and more that ten years with databases generally. I have extensive experience in database development with Oracle Clinicals. I have also worked as a database manager in Koblenz Germany, where I was responsible for overseeing databases for over 100 companies some of which includes BAAN, Siemens, Opel, Volkswagen, etc., and supervised 11 employees in my team. I am fluent in German.

EDUCATION

M.Sc., Management Information System (MIS). University of Maryland University College.

In Progress

B.Sc., Geology. (With Honors) University of Sierra Leone 1992,

Certifications:

MCSE (Microsoft Certified Systems Engineer) 1999, MCDBA (Microsoft Certified Database Administrator) 1999, CNA (Certified Novel Administrator) and Oracle Administrator 1999, and Oracle Clinical Development 2000.

RELEVANT PROJECT EXPERIENCE

Inventiv Clinical (April, 2010 to Present)

Chronic-Dose Comparison of the Efficacy and Safety of Albuterol Spiromax and Placebo in Subjects 12 years and older with (mild-to-moderate) Persistent Asthma. This is a multicenter, randomized, double-blind, placebo-controlled, repeat dose, parallel-group study to compare the bronchodilator response of Albuterol Spiromax to Placebo in male and female subjects (ages 12 and older) with persistent asthma.

Westat (October, 2002 to April 2010)

Cancer Trials Support Unit (CTSU)

Client: National Cancer Institute (NCI)

Project Overview: Westat is the prime contractor for the CTSU, a service offered by NCI to enhance and facilitate access to cancer clinical trials by investigators in the United States and Canada. The CTSU maintains a broad menu of trials developed by the adult cancer Cooperative Groups and other research consortia and works with these organizations to offer patient enrollment, data collection, data quality management, and enrollment reimbursement services to sites entering patients in these trials. In addition, the CTSU offers a regulatory support service to all adult cancer clinical trials by collecting regulatory documents and maintaining a national database of investigators and sites. The CTSU also provides education and training for clinical staff and clinical trials promotion services to help increase enrollment in cancer trials. A large and complex information technology infrastructure has been developed to support CTSU operations and exchange data with other data centers involved in cancer research. Westat has two subcontractors and works with numerous other organizations.

Responsibilities: Oracle Clinical developer. I participate in the setup and testing of clinical studies in Oracle Clinical. Create database objects in the global library, create data entry screens, and prepares documentation for Oracle Clinical developer procedures. Responsible for programming and testing data validation and derivation procedures and participate in software validation and applications testing. Enters project setup data into the database, grant privileges to database users, and has assists in training and supporting data management staff.

Cancer Chemoprevention Clinical Trials Monitoring and Informatics Support

Client: National Cancer Institute (NCI)

Project Overview: This 5-year project provides NCI’s Division of Cancer Prevention (DCP) with personnel and computer systems to ensure that clinical trials proceed safely and according to protocol. Westat is responsible for (1) clinical data monitoring, procedures for receiving trial data from study sites and conducting quality and completeness reviews, and data entry into the central database; (2) auditing, including management of site monitoring visits; (3) education and training on clinical trials management for site staff; and (4) informatics to develop and maintain a centralized database compatible with other DCP Enterprise applications.

Responsibilities: Oracle Clinical developer. I participate in the setup and testing of clinical studies in Oracle Clinical. Create database objects in the global library, creates data entry screens, and prepares documentation for Oracle Clinical developer procedures. Responsible for programming and testing data validation and derivation procedures and participates in software validation and applications testing. Enters project setup data into the database, grants privileges to database users, and has assisted in training and supporting data management staff.

Phase IV Drug Effectiveness and Usage Patterns

Client: Commercial Client

Project Overview: This phase IV post marketing study evaluated the effectiveness and usage patterns associated with a marketed anti-infective. In the first year, data were collected from 1,000 patients being treated for various Gram-positive infections in private practices and hospitals. Westat is responsible for project management, site management, site contract negotiations, regulatory assurance, data management, and data analysis and reporting.

Responsibilities: Oracle Clinical developer. Responsible for database development.

Adolescent Medicine Trials Network (ATN)

Client: National Institutes of Health

Project Overview: Westat is the data and operations center for the ATN, which evaluates behavioral, microbicidal, prophylactic, therapeutic, and vaccine modalities in adolescents with and at risk for HIV infection. Westat provides methodologic and statistical expertise for protocol and forms development, study design, data monitoring, data analysis, and manuscript and report preparation. Project staff develops and maintain Oracle databases; design and implement distributed and centralized Oracle Clinical systems for data entry, editing, storage, and retrieval; and coordinate data capture and transfer to other research networks for collaborative projects. Westat also manages regulatory compliance, supervises data collection, produces study manuals, trains staff in protocol implementation and quality assurance, performs site monitoring, and maintains an email system and web site.

Responsibilities: Oracle Clinical developer. I participate in the setup and testing of clinical studies in Oracle Clinical. Create database objects in the global library, create data entry screens, and prepares documentation for Oracle Clinical developer procedures. Responsible for programming and testing data validation and derivation procedures and participates in software validation and applications testing. Enter project setup data into the database, manage user accounts (allocating privileges to database users), and has assisted in training and supporting data management staff.

International Pediatric and Perinatal HIV Studies Network Coordinating Center

Client: National Institute of Child Health and Human Development (NICHD)

Project Overview: Under this contract, Westat serves as the NICHD Coordinating Center for multicenter Pediatric AIDS Clinical Trials Group protocols of therapies for HIV-infected children, adolescents, women, and pregnant women seen at clinical centers in the United States, Puerto Rico, Brazil, India, Argentina, Mexico, and the Bahamas. The network includes 27 main sites. Westat’s role includes negotiating and managing budgets and subcontracts with all clinical centers, training clinical center staff, performing site monitoring, assuring regulatory compliance, processing clinical center data, and conducting data analysis. Westat also provides full-service support for a phase III trial and three epidemiologic studies.

Responsibilities: Oracle Clinical developer. I participate in the setup and testing of clinical studies in Oracle Clinical. Create database objects in the global library, create data entry screens, and prepares documentation for Oracle Clinical developer procedures. Responsible for programming and testing data validation and derivation procedures and participates in software validation and applications testing. Enter project setup data into the database, manage user accounts (allocating privileges to database users), and has assisted in training and supporting data management staff.

Phase I and II Clinical Trials to Evaluate the Safety and Pharmacokinetics of a New Therapeutic for Neonatal Sepsis

Client: Commercial Client

Project Overview: Westat was responsible for data collection, management, and analysis; clinical site management and monitoring; and pharmacy monitoring. More than 130 newborn infants of low birth weight were enrolled from 20 sites in the United States.

Responsibilities: Oracle Clinical developer. I participate in the setup and testing of clinical studies in Oracle Clinical. Create database objects in the global library, create data entry screens, and prepares documentation for Oracle Clinical developer procedures. Responsible for programming and testing data validation and derivation procedures and participates in software validation and applications testing. Enter project setup data into the database, manage user accounts (allocating privileges to database users), and has assisted in training and supporting data management staff.

Phase III Trial of a Dry Eye Medication

Client: Commercial Client

Project Overview: Westat was responsible for project management, site management, site contract negotiations, site monitoring, regulatory assurance, data management, data analysis, and reporting. More than 900 patients were enrolled at 12 eye clinics.

Responsibilities: Oracle Clinical developer. I participate in the setup and testing of clinical studies in Oracle Clinical. Create database objects in the global library, create data entry screens, and prepares documentation for Oracle Clinical developer procedures. Responsible for programming and testing data validation and derivation procedures and participates in software validation and applications testing. Enter project setup data into the database, manage user accounts (allocating privileges to database users), and has assisted in training and supporting data management staff.

RELEVANT JOB EXPERIENCE

• Inventiv Clinical (April, 2010 to Present)

• Lead Oracle Clinical Developer for 3 simultaneous Asthma Studies overseeing 4 other developers

• Design, build and validate data entry screens for both PDF and classic studies

• Define, implement and test data quality checks in PL/SQL according to the data management plan

• Design and/or manage Oracle Clinical global library.

• Mentor and Train junior level clinical programmers

• Westat (October, 2002 to April 2010)

As a Data Management Associate (Oracle Clinical Database Developer), I work on all projects performing the following tasks:-

• Play a lead developer role for many studies

• Participate in the setup and testing of clinical studies in Oracle Clinical (OC)

• Creating database objects in the Global Library

• Creating data entry screens in both OC 4.3 and 4.5

• Prepare reports from database queries for supervision

• Create documentations for WESTAT Oracle Clinical Developer procedures

• Programming and testing of data validation and derivation procedures

• Participating in software validation and testing of applications

• Entering project setup data into the database

• User Accounts Management (allocation of privileges to users in Oracle Clinical

Database)

• Training and Supervision of Data Management Staff (CDMs and DRAs).

• Provides guidance to Clinical Data Coordinators relative to database design issues

• As a member of the OC troubleshooting team, I install all OC related software and troubleshoot all Accounts and OC problems.

• Work with RDC (Remote Data Capture), EDC (Electronic Data Capture)

• Work with AERS (Adverse Events Reporting System)

• Work with Quillix (CDIMS) 'Clinical Data Image Management Systems', and work with PL/SQL to create the necessary packages that we need for the databases

• I also have extensive experience working with SQL Server 2005 and 2008, Oracle 10g

administration.

• Strong background in SQL, PL/SQL Programming.

• May 2002 to October 2002 – Northrop Grumman Information Technology, Bethesda, Maryland.

Position: – Temp Database Administrator. My responsibility included installation of operating system and database based on studies made on company requirement, replication of data on SQL servers, database backups, database configuration and performance tuning, database upgrades, system disaster recovery and usage reporting, perform queries on the databases etc,

• Jun. 1998 to Dec. 2001 – Buro Organization GmbH Koblenz (A semen’s sister consulting company in Germany.)

Position: – Database Manager: Database consultant for more than 100 Customers throughout Germany, Some of which included Opel, BMW, and Baan etc.

My responsibilities included developing and implementing tangible backup strategies with Arcserv and Varitas backup tools. Perform network management services, such as create and modify user profiles and account management. Installation of company accounting product, and conduct lectures on usage of product and database, identify potential areas where existing policies and procedures require changes. Analyze client requirement and recommend appropriate hard and software. Develop and maintain a solution database with resolution techniques to resolve network and database problems quickly and efficiently. Install, configure and upgrade MSSQL server and Oracle based on the company’s requirements. Database fine tuning, Configuration and Upgrades, system disaster recovery and usage reporting. Develop and implement data replication strategies etc.

• April 1994 to Feb. 1998 – Firma Lignotock GmbH NRW – Germany.

Position: - Assistant Network Administrator. My responsibilities included assisting the Administrator with installations of operating systems, and databases. Build and configure networks. Backup and tune Operating Systems. Create new users and user profiles. Helping coworkers with daily computer problems in word, excel, access, power point presentations etc.

OTHER PROFESSIONAL EXPERIENCE

I possess extensive hands-on technical experience in the installation, configuration, and troubleshooting of Microsoft operating systems, the databases MSSQL server and Oracle 8.0. As an addendum, I have a very good experience in HP UNIX. My other skills include the making of home pages and designing with visual basic. I also speak perfect German.

REFERENCES

Available upon request.

OTHER COMTACT INFORMATION

EMAIL:

*******@*****.***

TELEPHONES:

Home: 301-***-****

Cell: 301-***-****

Contact this candidate