Curriculum Vitae

• Proven experience in development and implementation of clinical standards in a global pharmaceutical environment. Experience in consulting projects dealing with the assessment, design and/or implementation of CDISC data standards in the clinical data life cycle

• Provide oversight and direction of data manager activities, including quality and timeliness of
product deliverables, process improvement, resource allocation, and training and development of
personnel
• Assist in developing and/or implementing strategies and policies for data management that are
aligned with maximizing quality and reliability of deliverables at an optimized cost
• Assist with implementation of improved processes and management methods to ensure
attainment of the company’s business plan for growth and profit
• Manage data management specialist activities by directing and coordinating activities consistent
with established goals, objectives, and policies of the company, and manage expectations of clients
• Create or direct the production of SOPs related to data management activities
• Provide input to the preparation and execution of budgets and timelines
• Evaluate data management processes, activities, and deliverables, including hardware and
software necessary to accomplish activities and documentation of processes adequate to meet
external auditor requirements
• Provide mentoring and guidance to subordinates and other employees, including the coordination
of training
• Provide assigned staff with performance goals, feedback, and improvement opportunities
• Conduct timely performance evaluations for all direct reports
• Perform data management functions as needed:
o Review/prepare data management plans
o Review/design case report forms
o Review annotations/annotate case report forms
o Review the design of EDC databases
o Perform system administrator functions for EDC system
o Track and report on project data management status
o Coordinate contact with clients as relate to project data issues
o Review/perform data management quality control (QC)
o Review/perform data management activities for external electronic data capture databases
(e.g., project administration, case report form review, user acceptance testing)
o Review importation/import external datasets
• Serve as primary contact and/or program manager for projects as needed
• Manage client expectations, including the scope and timeline of work for the project
• Participate in scientific and regulatory meetings as requested
• Serve as a member of management teams as necessary
• Perform any other duties assigned

Additional skills, experience, and knowledge documented in my CV/Resume.

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