SUMMARY:

This position will act as the lead clinical data manager for clinical (Phase I-IV) trials as assigned. The person is responsible for providing input to protocols, design and review case reports forms, provide input to database development and perform all data management related activities. The person is expected to ensure that the clinical data management elements are in line with the overall deliverables and to ensure adherence to ICH guidelines, Good Clinical Practices, and regulatory requirements.

RESPONSIBILITIES:

• Represent clinical data management in meetings with internal cross-functional and external customers

• Act as the Lead data management team member in clinical development

• Perform or support data management activities for multiple studies in different indications. The responsibilities include CRF development, CRF review, database specifications, user acceptance testing, query resolution, data review and data completion.

• Interact with clinical operations, medical monitors and biostatistics/Programming periodically on the progress on the data entry, and quality

• Interact with external data management vendors and subsidiaries of Spectrum

SKILLS, EDUCATION AND EXPERIENCE:

• 4 year degree preferably in biologic sciences; MS preferred
• 5-8 years data management experience in the Pharmaceutical, Biotechnology, or Contract Research Industry
• Ability to clearly communicate processes and standards with management and team members.
• Hands-on knowledge of data management activities, clinical database design, specifically electronic data capture from various vendors
• Knowledge of SDTM models and experience transforming raw data into those standards.
• Knowledge of:

               o          Data Management and Pharmacovigilance processes in clinical trials.

               o          Relational databases.

               o          Good clinical practices.

                o        21CFR Part 11 standards.

                o        Safety data and coding dictionaries

POSITION LOCATION AND/OR TERRITORY AND TRAVEL

• Position is located in Irvine, CA.

Required Skills Required Experience