Clinical Data Lead
- 3+ years experience as a Data Manager, working in studies across all phases and a variety of therapeutic areas
- 1+ year of experience as FSP to a major pharmaceutical sponsor; led trials to success from study build to database lock
- Experienced in all aspects of data management for clinical trials, including CRF development, database build, custom report writing, tSDV/RBM configuration, external data reconciliation, change management, and database.
- Primary point of contact for day-to-day activity on a study; work independently to meet study objectives and address sponsor needs, reporting to the Project Manager
- Supervise data management support team and coordinate with both internal and external study team to meet or exceed monthly KPIs for data cleaning, data delivery, resourcing, and change management during maintenance
- Experienced in writing study documents, including draft eCRF, CRF completion guidelines, Data Management plan, and custom listings specifications