Clinical Data Manager

Description

Clincial Data Manager

A large pharmaceutical company in South San Francisco is looking to hire a new Clinical Data Manager. This is an excellent opportunity for any qualified candidate to join a great company.

Clinical Data Manager Duties:

Experience with managing a rescue study environment

Experience with managing vendors from a Sponsor's perspective (CRO and EDC)

Acorn is the current DM CRO vendor

Omnicomm is the current EDC vendor

Experience with EDC start-up (Omnicomm Trialmaster preferred)

Experience with Project Management and Communication

Ability to handle multiple, competing priorities

• Recruits, trains and manages employees and consultants with area of responsibility; support development training standards
• Contributes to technical infrastructure of the Data Management and process improvement
• Provides operational leadership to the direction, planning, execution, collection and handling of all clinical data to the highest quality standards while ensuring the Onyx established standards
• Manages DM related timelines. Coordinates and synchronizes deliverables / milestones with the overall Study Execution Team timelines
• Responsible for building effective DM vendor relationships for all assigned studies. Involved in RFP development, contract negotiation and selection of DM and/or technology, as needed Escalate issues with proposed solutions, as necessary
• Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications
• Implements methods of achievement of major reporting deliverables and milestones for regulatory submissions
• Working with IT, ensures that local IT infrastructure meets Biometrics needs and global standards
• Represent DM in Study Execution Team (SET) meetings; establishes and negotiates timelines with internal and external team members for completion of activities for a group of projects
• Project management for programming deliverables for one or more projects as required
• Supports budget and resource planning across one or more projects
• Develops, applies and promotes consistent Data Management standards through standard processes and SOPs
• Manages group of internal data managers, consultant data managers. Mentors and develops direct employees
• Provide training of the CRF completion guidelines, EDC system at Investigators' meeting and to internal and external project members as needed

This large pharmaceutical company is looking to fill this Clinical Data Manager role immediately. If interested in this position please reply to this advertisement as soon as possible.

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