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Senior Data Manager

New Jersey All, NJ

Post Date: 11/28/2017 Job ID: JN -112017-20474 Job Type: Data Management - Clinical
  • Responsible for managing all data collection, processing and delivery aspects in the assigned clinical studies
  • This includes developing and implementing study-level data management planning to ensure that the outsourced and in-house activities are completed according to the agreed scope, quality standards and timelines
  • Responsible for day-to-day coordination of ongoing data management activities acting as data management functional representative in the study teams
  • Working with internal and external cross-functional teams, will coordinate design, validation, implementation, and maintenance of data acquisition instruments and modalities, validation and finalization of study databases, and preparation of data management deliverables for ongoing data monitoring and for use in the interim and final analyses
  • Serve as the subject matter expert on topics related to data management activities
  • Contributions include, but are not limited to: vendor selection and management, representing data management function in the clinical operation team for the assigned studies, collaboration with global data science staff (data management, statistics, clinical pharmacology, programming), collaboration with Clinical Development staff, cross-functional collaboration with other departments and the global organization
  • Support outsourcing activities by providing input on data-related budget, scope and requirements (e.g. RFP, scope of work, vendor costing, change orders, etc.), vendor selection and management, risk and communication management, and application of best data management practices and regulatory requirements
  • Coordinate development of study-specific data acquisition solutions (paper and/or electronic) that adhere to the study protocol, the development program, industry regulations/standards, and Company standard procedures; this includes overseeing the specification/design, validation, and implementation, maintenance, decommissioning and archiving steps, relevant planning, quality control and documentation
  • Manage clinical data processes to ensure integrity and adequate quality of data, including the outsourced or in-house validation and reconciliation of all study data modalities, review of data transfers, data transformation and mapping (specifications and actual data structures), planning and implementation of data quality review
  • Accountable for data management activities to support the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of programmed protocol deviations, manual data listings, and coordination of in-house interim and final Data Review Meetings, preparation and completion of the associated documentation
  • Responsible for coordinating routine study-level data management activities in accordance with the study project plan, including but not limited: eCRF and eCOA/ePRO design; system integration, validation and UAT; edit checks; study-specific data management procedures; data management plans and reports: coding of medical terms, SAE and external data reconciliation; query resolution; mapping specifications; completion of data management portion of the trial master file
  • Participate in the development, review and updating of data management SOPs and working practices
  • Participate in process improvement initiatives
  • Perform other departmental duties as assigned
  • Bachelor's or Master's degree or equivalent in Natural or Life Sciences, Computer Science, or Medical Informatics
  • 7 to 10 years of study and/or project level experience as Data Manager in leading roles in pharma or biotech environment and various stages of drug development (Phase I, II, III)
  • Significant experience in using data management technologies (electronic data capture and eCRF, eCOA/ePRO, relational databases, data review and visualization tools)
  • Experience in CDISC data standards (SDTM, ADaM, define.xml); experience in CDISC validation tools a plus
  • Experience in outsourcing models
  • Basic SAS programming knowledge and/or programming, scripting, SQL skills a plus
  • Knowledge of the drug development process
  • Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, FDA guidelines and European Clinical Trials Directive, Privacy rules (HIPPA))
  • Good general computer skills (Microsoft Office applications, common file formats, etc.)
  • Strong organizational and communication skills and ability to collaborate effectively with other groups in a matrix organization
  • Able to collaborate with minimal supervision
  • Able to concurrently work on several clinical studies
  • High standards of business conduct and ethics

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