Director, Data Management

AlkermesWaltham, MA
$205,000 - $230,000

About The Position

This role provides strategic and operational leadership for Clinical Data Management activities supporting the company's clinical development portfolio. This position is responsible for ensuring the delivery of high-quality, reliable, and inspection-ready clinical data through effective planning, oversight, and execution of data management activities across both internally managed and outsourced clinical studies. The Director partners closely with cross-functional stakeholders, including Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Clinical Systems, Quality Assurance, and external vendors, to define study-level data management strategies, ensure regulatory compliance, and drive continuous process improvements. This position also provides leadership for departmental initiatives, people development, and operational excellence.

Requirements

  • Strategic and operational leadership experience in Clinical Data Management.
  • Experience ensuring the delivery of high-quality, reliable, and inspection-ready clinical data.
  • Experience with planning, oversight, and execution of data management activities for clinical studies.
  • Experience working with cross-functional stakeholders including Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Clinical Systems, Quality Assurance, and external vendors.
  • Experience defining study-level data management strategies.
  • Experience ensuring regulatory compliance.
  • Experience driving continuous process improvements.
  • Leadership experience for departmental initiatives, people development, and operational excellence.

Responsibilities

  • Provide strategic and operational leadership for Clinical Data Management activities.
  • Ensure the delivery of high-quality, reliable, and inspection-ready clinical data.
  • Oversee and execute data management activities for internally managed and outsourced clinical studies.
  • Partner with cross-functional stakeholders (Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Clinical Systems, Quality Assurance, external vendors) to define study-level data management strategies.
  • Ensure regulatory compliance.
  • Drive continuous process improvements in data management.
  • Provide leadership for departmental initiatives, people development, and operational excellence.
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