Employment

Title of Position:  Oracle Clinical Programmer

Job Code # 08037

Location:  Rockville, MD

Applicants must meet the following requirements:

• Bachelor's or Masters degree in life sciences or computer science degree.
• A minimum of 5 years of experience in Pharmaceutical or Biotech industry responsible for programming in a large scale clinical data management system.  Proficiency with Oracle Clinical and Oracle based data management tools, including SQL and PL/SQL. 
• Experienced in the design, documentation, testing and implementation of clinical study databases and processes, including Electronic Data Capture tools
• Demonstrated knowledge and understanding of data management standards and methodologies, GCP, ICH and FDA regulations and guidelines, including 21 CFR Part 11, along with CDISC standards. 
• Experience in clinical study data management operations is helpful.
• Oracle Clinical and EDC experience preferred.
• Experience using a clinical data reporting tool, such as Integrated Review.
• Above average organizational, interpersonal, and communication (oral and written) skills required.
• Able to perform job with minimal guidance.

The selected candidate will be responsible for:

• Create, test, validate, implement and maintain clinical studies in Oracle Clinical (OC). This includes assisting in design and build of CRFs, programming for data entry verification and validation (edit checks) and case report form processing.
• Take a lead role in the development, implementation and maintenance of standards in the GLIB using CDISC.  Assist in the creation and maintenance of Study Operation manuals.
• Interact with clinical and safety teams to provide integrated data capture and presentation of information. Assist with presentation of data for clinical and regulatory reports.
• Using SQL, PL/SQL, ad hoc tools (i.e. Integrated Review) and SAS, create programs used for review, clean-up and transfer of data collected during Clinical Trials.  Provide compliance, and  metric reports on database operation.
• Perform basic database administration activities including daily monitoring, backups, routine maintenance and minor troubleshooting.  Assist with Oracle database, Oracle AERS and Oracle Clinical software validation and compliance.
• Ensure standards and level of quality are maintained at the highest level for all activities.
• Work with outside vendors (CROs, laboratories, etc.) to complete study related data management activities. 
• Assist in development and implementation of new processes ensuring Data Management programming policies, guidelines and procedures are followed during day-to-day assignments.
• Participate in all study team meetings providing a single point of contact for all data management related activities and deliverables.
• Recommend and participate in overall process improvements for data management.

Benefits:  Competitive salary and benefits package

Qualified applicants with current permission to work in the United States, please send your resume and salary history to:

Human Resources 
MacroGenics, Inc.
1500 East Gude Drive
Rockville, MD 20850
E-mail:  HResources@macrogenics.com

MacroGenics, Inc. is an Equal Opportunity Employer.