Position Summary:

The 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 Principal Clinical Database Manager may play a lead role in internal software projects that require specialized programming and/or scripting.  

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

  • Maintains responsibility of assigned projects. Ensures on-time delivery, communicates the status of projects to internal teams and study
  • 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
  • Participate in conducting EDC demonstrations and trainings
  • Participate in the development and maintenance of Standard Operating Procedures (SOPs) and corresponding process documentation related to data management and database management activities
  • Provide leadership for cross-functional and organization-wide initiatives, where applicable
  • 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
  • Provide technical guidance and advice to key senior leadership on reasonable growth and process goals to assure data quality
  • May require some travel
  • Perform other duties as assigned

Qualifications:

Minimum Required:

  • 5+ years’ experience with strong Medidata EDC build background.  
  • 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
  • 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

 Preferred:

  • Medidata custom function programming or C# (C-Sharp) programming experience
  • Oracle InForm Central Designer experience
  • Oncology and/or Orphan Drug therapeutic experience
  • Base SAS®, SAS/STAT and SAS/ACCESS software
  • SAS Macro programming language
  • Advanced experience in Database Management, object-oriented programming

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