Senior/principal Clinical Database Manager

Description:

The Senior/Principal Clinical Database Manager is responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. 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. Provides operational and technical training to end users and junior staff. Additionally, the Senior/Principal Clinical Database Manager may play a lead role in internal software projects that require specialized programming and/or scripting.

Qualifications

Minimum Required:
 

• Must have experience in developing and customizing clinical data management databases in a clinical, scientific or health care discipline
• Bachelor’s and/or a combination of related experience
• Medidata Rave EDC Certified Study Builder
• Rave API integration experience using external vendor modules
• Rave Advanced Custom Function programming 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.
• Experience in Object Oriented Programming (C#, C++, VBS, etc.…), scripting language (PERL, etc.), SAS, R, SQL
• Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.)
• Experience in clinical database management system development.
• Experience in a clinical, scientific or healthcare discipline.
• Experience in utilizing various clinical database management systems
• Broad knowledge of drug, device and/or biologic development and effective data management practices
• Strong leadership and interpersonal skills
• Must be able to communicate effectively in the English language.