Principal Lead Clinical Data Manager

This is an opportunity to join a company in Southern Californiathat is dedicated to discovering and developing more effective medicines for the treatment of cancer. As a Principal Lead Clinical Data Manager you will be responsible for leading and overseeing all activities of data management for clinical trials from start up to close out. You will work with internal development colleagues and external clients to ensure delivery to time, quality, and cost expectations, and perform day-to-day data management activities according to ICH guidelines, regulatory requirements, and the company's standard operating procedures.

Position Responsibilities:

- Ensure that management's clinical development objectives are met with regards to Data Management activities
- Provide operational leadership to the direction, planning, execution, collection, and interpretation of all clinical data to the highest quality standards
- Report status of clinical data management activities to project teams and management
- Involved in data preparation for reporting clinical study results for regulatory filings, publications, presentations
- Develop and implement data management standard operating procedures and create written data management plans
- Design database structures and case report forms consistent with CDISC and CDASH initiatives
- Work with third-party vendors to develop data transfer specifications
- Train, supervise, and manage junior data management personnel and CRO/internal staff as appropriate

Requirements:

- Bachelors or advanced degree
- Minimum 10 years' experience managing clinical trial data in a pharmaceutical, biotech, or CRO setting; oncology trial experience desired

To find out more about Real please visit www.realstaffing.com