Senior Clinical Database Manager

November 14

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pfm medical, inc.

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Medical Device Manufacturing

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Description

• Responsible for the design, development, testing, implementation, maintenance and support of clinical databases and applications. • Interface directly with internal teams, EDC vendors, clients, and third-party vendors to gather requirements and provide status updates. • Provides operational and technical training to end users and junior staff. • May play a lead role in internal software projects requiring specialized programming and/or scripting.

Requirements

• 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. • 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. • Oncology and/or Orphan Drug therapeutic experience (preferred). • Base SAS®, SAS/STAT and SAS/ACCESS software (preferred). • SAS Macro programming language (preferred). • Advanced experience in Database Management, object-oriented programming (preferred).