Description:
The individual will be part of the Research and Development Group (R&D) which is responsible for all FDA related research and supports all non-FDA company sponsored research.
The team allows 1 day of working from home, after training/when company deems it is appropriate to begin.
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 training 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
• 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
Education and Experience Required:
• 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 mi1d 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
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