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Senior Clinical Data Manager (New Jersey)

Location: Bedminster Salary: competitive
Sector: Pharma & Biotech Type: Contract

Our client is seeking at Clinical Data Manager to join their on a long term contract that has an opportunity to go permanent.

Primary Job Responsibilities:

  • Create and review (electronic) Case Report Forms per Protocol and annotated Case Report Forms
  • Review Protocols to ensure database feasibility
  • Develop/build, review, and maintain a clinical database and supporting specifications documentation
  • Develop/build, document and perform validation of database structure, data capture screens, code lists, edit checks, reports and other functions in EDC (e.g. User Acceptance Testing)
  • Develop data transfer agreements and specifications with various vendors
  • Write, review and maintain eCRF completion guidelines, data management plan (DMP), data validation plan (DVP, e.g. edit checks), and other DM related documentation
  • Perform all aspects of DM process as related to processing and QC of the data
  • Clean data for study close out and perform all database lock procedures
  • Manage reconciliation with any external data (e.g. SAE, lab)
  • Monitor study status (e.g. enrollment, CRFs, etc.) and provide status reports to the team
  • Use standard conventions, tools, references and process in support of the coding of medical terms
  • Ensures all DM procedures executed with a high attention to detail, accuracy and timelines
  • Represent the DM function on project teams
  • Write and review DM SOPs in accordance with GCP and ICH guidelines, and develop associated raining and competency testing
  • Maintain CRFs m1d database standards
  • Work in conjunction with Clinical Operations, Clinical Research, and other operations to ensure accurate, efficient, and complete data collection
  • Mentor junior level staff on database management tasks and processes
  • Contribute/participate in data management initiatives
  • Other duties as assigned

Experience:

  • Proficient in Microsoft Office applications (PowerPoint, Microsoft Word, Microsoft Excel, etc.), Internet software, E-mail
  • Proficient with Clinical Data Management Systems (CDMS) and experience with Electronic Data Capture (EDC) systems
  • Experience with SAS (Base, Stats, Macro, etc.)
  • Experience with CDISC SDTM/CDASH
  • Experience with study database build (including edit check programming)
  • Experience in software development, software implementation, testing and validation
  • B.S. in Mathematics/Statistics, Computer Science, Life Sciences or related field
  • Minimum 8 years of data management experience in the pharmaceutical or biotechnology industry
  • Highly organized and detail-oriented with effective planning with strong verbal and written communication skills
  • Flexibility mid agility to adapt to changing scope of work, able to propose thoughtful solutions to challenges and issues, proactively implement solutions, and communicate effectively with colleagues
  • Experience/knowledge of GCP and ICH guidelines

Sthree US is acting as an Employment Business in relation to this vacancy.