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Job Details

Clinical Data Manager
Hampton, NJ  Posted: 3/5/2019


Job Overview
Provides timely, effective and professional ongoing Data Management of clinical trial data for multiple trials with respect to cost, quality and timelines for assigned trials managed within Clinical Data Management. This includes supporting activities for database setup/startup, conduct and database finalization/lock. Ensures high quality data is available for analysis and reporting.
  1. As Trial Data Manager (TDM) provides Data Management leadership across multiple trials
  2. May have responsibility for a small program or indication within a large program
  3. Possesses strong project management skills to successfully manage multiple trial-related activities and activities across trials
  4. Takes ownership of and leads the DM activities for start-up including preparing the data collection instrument requirements/database design and development support/edit checks, CCGs, DMP and performs User Acceptance Testing (UAT) as necessary
  5. Obtains input from study team members on the design of clinical databases while ensuring data quality and compliance with SOPs
  6. Reviews and contributes to preparation of protocols, specifically related to the Visit Evaluation Schedule (VES), Study Design and Data Management section
  7. Develops and manages the Data Handling Plan (DHP) and Data Review Plan (DRP) for assigned trials
  8. Participates in the development of training materials for Investigator Meetings
  9. Presents at Investigator Meetings (if needed)
  10. Develops training materials and /or tools for conduct of the study
  11. Disseminates study-level information to the Study Team
  12. Understands study-level metadata
  13. Responsible (and accountable) to ensure consistency of assigned trials with a program or indication (DHPs, DRPs and eCRFs/CCGs)
  14. Communicates with 3rd party data providers/vendors to define the schedule and process for transfers of data
  15. 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
  16. Responsible and accountable to ensure project documents (eCRF, CCGs, DMPs) meet sponsor/client requirements and are consistent (if applicable)
  17. Demonstrates the skills to review data at an aggregate level and identify trends, outliers, and within range anomalies
  18. Utilizes status and metric reports to identify training needs and issues with investigator sites or project teams
  19. Recognizes difficult issues and seeks assistance from experts or escalates as required to ensure quality and timelines are not jeopardized
  20. Establishes and maintains project-specific project plans and is responsible for keeping them current, proactively monitoring them and communicating any concerns
  21. Independently coordinates DM activities performed by self or others to ensure timely completion
  22. Mentors and trains junior staff/new hires for assigned trials
  23. Takes ownership of and leads the DM activities for database finalization/lock activities ensuring submission-ready quality data
  24. Maintains effective working relationships with sponsors/clients and vendors
  25. Has a working understanding of database design principles and of technology platforms
  26. Understands CDISC or other recognized industry standards
  27. Adequately prepares for project audits and can respond knowledgeably to DM questions that arise during audits
  28. For trials where no Program Data Manager (PDM) is assigned, assumes the accountabilities and responsibilities of the role of PDM when required
  29. Able to propose solutions to resolve issues which may arise when handling 3rd party data from non-standard providers
  30. Possess an understanding of regulatory topics and sponsor obligations as related to CRO and 3rd party providers. Able to represent DM in study-level inspections
  31. Able to provide effective DM input in process improvement efforts to systematically resolve issues that occur on outsourced trials
  32. Ensure 3rd Party and Serious Adverse Event (SAE) reconciliation activities are performed in a timely manner and according to SOPs and processes
  33. Acts as subject matter expert as assigned
  34. Mentors and trains new colleagues and/or other team members as assigned
Key Performance Indicators
Delivery of timely, high quality data management deliverables per objectives

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