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Home-Based Senior Clinical Data Manager

New Jersey All, NJ

Posted: 05/14/2019 Job Type: Clinical Job Number: JN -052019-24885

Summary of Key Responsibilities:

  • Serves as the Project Manager for all Data Management deliverables
  • Primary contact for the client for all Data Management issues
  • Participates in bid defense meetings, proposals, etc.
  • Accountable to the client and to the Project Manager for the delivery of all Data Management deliverables on time and with high quality
  • The Sr. CDM will have mastered the CDM position and is expected to handle all client interactions with minimal support from management

Duties include but are not limited to:

  • Leads cross functional Data Management teams (Statisticians, Programmers, Data Manager) to plan for and deliver all data deliverables; this includes creating and managing all timelines and project plans

This includes but is not limited to:

  • CRF design
    • Database design and testing
    • Report specifications and testing
    • Data Management Plan development
    • Development of data quality checks
    • Management of data sources from outside vendors
    • Delivery of a locked database
    • Management of all mid-study changes to the database
    • Represent Data Science externally in Business Development activities
    • Represent in the development and implementation of internal process improvement initiatives
    • Participate in the training and mentoring of junior staff including Clinical Data Analysts
    • Key liaison with client to ensure the highest possible customer service in order to win repeat business
    • Enforces data standards with project team, physicians and clients
    • Identifies data science scope changes and provides cost analysis to the project manager for these scope changes
    • Promotes effective teamwork among members of the data science team
    • Directs activities of Clinical Data Analysts
    • Communicates and escalates unresolved issues at the appropriate time and to the appropriate level of management
    • Accountable for compliance to all SOPs and regulatory requirements
    • Accountable for ensuring all required documentation is created and filed in the Trial Master File
    • Works with Manager and Director to forecast resources
    • Manages special assigned projects such as data standards, system implementations, validation efforts, etc.
    • Reviews budgets and proposals and provides feedback to Business Development

Requirements:

  • Bachelor s College; Master's Degree is a plus
  • At least 5 years of CDM experience
  • Minimum of 3 years of DM Lead experience
  • Recent experience at a CRO specifically in the DM Lead position is required
  • Experience managing multiple teams as well as interdisciplinary teams
  • Experience working with and negotiating with external clients

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