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Lead Data Manager

New Jersey All, NJ

Posted: 01/07/2019 Job Type: Clinical Job Number: JN -012019-23336
  • Provides timely, effective and professional ongoing data management of clinical trial data for one large/complex or multiple trials managed within Clinical Data Management
  • Ensures high quality data is available for analysis and reporting
  • Leads DM activities and across one large/complex or multiple smaller trials
  • May have responsibility for a small program for a client/sponsor
  • Takes ownership of and leads the DM activities for start-up including preparing the data collection instrument requirements/design/edit checks, CCGs, DMP and performs User Acceptance Testing (UAT) as necessary
  • Reviews and provides input into the preparation of Visit Evaluation Schedule, Study Design and Data Management sections of the protocol (if requested) and can recognize and communicate issues that may negatively impact database design, data cleaning or analysis/reporting
  • Develops DM training materials for investigator meetings
  • Presents effectively for DM at investigator meetings (if needed)
  • Participates actively at the Study Team level and contributes during meetings
  • Prepares training materials and reports/tools to support project conduct
  • Proactively communicates project information to Study Teams and to senior DM Team members/management (if needed)
  • Solicits input from Study Teams regarding clinical database design while ensuring compliance with SOPs and data quality
  • Communicates with 3rd party data providers/vendors to define the schedule and process for transfers of data
  • Oversees several different types of 3rd party data and can proactively problem solve issues and propose solutions with minimal management assistance
  • Takes ownership of and leads the DM activities for conduct such as ongoing review of clinical data listings (CRF, laboratory, SAE reconciliation, 3rd party vendor and coding data) for quality, content and format
  • Responsible and accountable to ensure project documents (eCRF, CCGs, DMPs) meet sponsor/client requirements and are consistent (if applicable)
  • Demonstrates the skills to review data at an aggregate level and identify trends, outliers, and within range anomalies
  • Utilizes status and metric reports to identify training needs and issues with investigator sites or Study teams
  • Recognizes difficult issues and seeks assistance from experts or escalates as required to ensure quality and timelines are not jeopardized
  • Establishes and maintains project-specific project plans and is responsible for keeping them current, proactively monitoring them and communicating any concerns
  • Independently coordinates DM activities performed by self or others to ensure timely completion
  • Mentors and trains junior staff/new hires for assigned trials
  • Takes ownership of and leads the DM activities for database finalization activities ensuring submission-ready quality data
  • Provides effective input into DM initiatives, process improvements and innovation efforts in the spirit of continuous improvement in operational excellence
  • Maintains effective working relationships with sponsors/clients and vendors
  • Authors SOPs, SWIs, standards for handling 3rd party data, change control processes with oversight
  • Provides input into bids, contracts, change orders for project scope changes (as needed)
  • Acts as subject matter expert (SME) as assigned
  • Has a working understanding of database design principles and of technology platforms
  • Understands CDISC or other recognized industry standards
  • Adequately prepares for project audits and can respond knowledgeably to DM questions that arise during audits
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