Clinical Database Manager

Position Summary:

The Clinical Database Manager I is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications under direct supervision.  Position will interface directly with the internal team (i.e. Data Management, Project Management, etc.), EDC vendor, clients and third-party vendors to gather requirements and provide status updates.

Essential functions of the job include but are not limited to:

• Provides input and guidance to the design of clinical databases to the client and internal teams
• Builds and supports clinical databases
• Develops, tests, and validates programs and clinical database to support client-related projects and third-party applications.
• May provide system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications
• Troubleshoots and resolves software and clinical database problems
• Develops and maintains study-specific validation documents
• May provide data management support for client-related projects from CRF design to post database close and archival
• May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.
• Participate in software vendor selection
• May participate in conducting EDC demonstrations and trainings
• May assist in participating in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
• Trains and ensures that all data management project team members have been sufficiently trained
• Communicate with study sponsors, vendors and project teams as needed regarding data, database or other relevant project issues
• Present software demonstrations/trainings, department/company training sessions, present at project meetings
• May require some travel
• Perform other duties as assigned

Qualifications:

Minimum Required:

• 1 years’ experience
• Bachelors and/or a combination of related experience

Other Required:

• Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
• Able to handle a variety of clinical research tasks.
• Excellent organizational and communication skills
• Professional use of the English language; both written and oral

Preferred:

• Experience in a clinical, scientific or healthcare discipline.
• Experience in utilizing various clinical database management systems
• Experience in clinical database management system development.
• Experience in Object Oriented Programming (C#, C , VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.…)