A Principal Clinical Data Manager (PCDM) will be responsible for performing all data management tasks at ARA. They will act independently as a lead data manager on multiple projects of potentially high complexity and act as support data manager on other projects as assigned. As a lead data manager on a project, they will be the primary point of contact for the client on data management topics and will manage the project timelines, resourcing, and budget for all data management-related tasks for that project. They may provide project oversight to other data management staff or act in a mentorship role.
A PCDM should be possess an understanding of therapeutic areas and indications under study by ARA clients and be able to identify and provide solutions to data management issues. They may be responsible for reviewing or preparing study documents as they relate to data management. They may be asked to review/prepare documents associated with regulatory submissions, attend meetings and/or provide responses to questions raised from a regulatory perspective. Familiarity with US and OUS regulatory requirements, guidance and trends is required.
PCDM may specify, build, manage or oversee team members in all aspects of database design and build. Knowledge of industry standards for data collection and reporting (ex. CDASH, CDISC) are necessary to both advise client database design and consider impacts and/or efficiencies as related to downstream programming and statistical reporting activities.