Director, Data Management

Data Management Director directs and oversees the design and development of systems used for managing data such as data warehouses, data stores, and other business intelligence systems. Responsible for maintaining and monitoring the data systems to ensure they meet organizational requirements. Being a Data Management Director requires a bachelor’s degree. Typically reports to top management. The Data Management Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Data Management Director typically requires 5+ years of managerial experience.

Director, Data Management Job Description Template

Our company is looking for a Director, Data Management to join our team.

Responsibilities:

  • Participate in the writing, review, and finalization of regulatory documents, CSRs, abstracts, and manuscripts for publication;
  • Manage data management resources and budget, biometrics vendors and CRO activities;
  • Provide strategic and tactical data management input for clinical trial design and analysis, including participation in protocol development process.

Requirements:

  • Experience working with and managing external biometrics vendors (CROs, etc.);
  • Courage to challenge stakeholders as well as team members for the best results;
  • Hands-on involvement;
  • High attention to detail including proven ability to manage multiple, competing priorities;
  • Statistical knowledge and experience a strong plus;
  • Extensive knowledge of data management methodologies used in clinical trials;
  • Ability to think outside the box and challenge status quo;
  • In-depth knowledge of the global drug development process; hands-on experience with clinical trials (Phase I to IV);
  • Flexible to ever-changing priorities internally and externally;
  • Knowledge of regulatory guidelines, including GCP, FDA/EMA/CHMP and ICH guidelines;
  • Experience with NDA, BLA, and/or MAA submission and related late-stage approval activities;
  • Excellent operational leadership skills, including collaboration and influence with key stakeholders and senior leadership;
  • Strong management skills, and ability to effectively lead and collaborate with various business functions;
  • Experience with both in-house and outsourced Biometrics models;
  • Ability to translate a vision into actionable work streams.