The Principal Clinical Data Manager (PCDM) leads the data management components of clinical trials with demonstrated subject matter expertise in all aspects of the Data Management (DM) discipline. The CDM is responsible for ensuring study launch, conduct, and closeout are performed according to company quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations. The PCDM is responsible for overseeing the start-up, execution, and closure of Elevar clinical trials whether outsourced to CRO or in-house, to ensure data quality and integrity. The PCDM will act as a primary data management liaison with vendors and senior management. The individual will oversee and perform a variety of complex tasks to ensure complete, accurate, high quality, and regulatory compliant data in support of publications and regulatory submissions. The PCDM will report to the Head of Clinical Data Management. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by senior data management when needed.
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