Lead Data Manager

IQVIADurham, NC

About The Position

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

Requirements

  • Minimum 7+ years of Clinical Data Management experience in pharmaceutical, biotechnology, or CRO environments.
  • Strong knowledge of clinical trial processes from study start-up through closeout.
  • Experience leading Data Management activities for global clinical trials.
  • Experience managing high-complexity studies, preferably in Oncology.
  • Hands-on experience with eCRF design.
  • Hands-on experience with edit check development.
  • Hands-on experience with query management.
  • Hands-on experience with database lock activities.
  • Hands-on experience with data reconciliation processes.
  • Experience with SDTM dataset management and clinical data transfers.
  • Strong understanding of CDISC, CDASH, and regulatory requirements.

Responsibilities

  • Lead Data Management activities for global clinical trials.
  • Manage high-complexity studies, preferably in Oncology.
  • Design eCRFs.
  • Develop edit checks.
  • Manage queries.
  • Oversee database lock activities.
  • Manage data reconciliation processes.
  • Manage SDTM dataset management and clinical data transfers.

Benefits

  • Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
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