Provides expertise on Clinical Data Management activities. Key Responsibilities:

• Plan and lead Data Management activities for multiple projects with accountability for successful completion, including conducting project team meetings, establishing project timelines, and communications to stakeholders.
• Develop and maintain Data Management deliverables, including data management plans, training materials, and user aids in compliance with regulations.
• Create complex metrics to identify trends in data and remediation, utilizing tools to assess need for training and provide recommendations.
• Define and specify clinically complex data collection requirements, including defining, performing, and coordinating user acceptance testing to ensure appropriate data are collected and validated.
• Provide guidance and recommendations to clinical team regarding data error evaluation, collection issues, and TFLs.

• Bachelor's Degree in a related field.
• 5 years' experience in Clinical Data Management (CDM).
• Experience in clinical research and post market surveillance project is required.

• Proven successful project management skills.
• Proven expertise in Microsoft Office Suite and EDC systems.
• Excellent documentation and communication skills, interpersonal relationship skills, and ability to drive achievement of objectives.
• English skills to communicate with a global team.
• Extensive knowledge of Clinical Data Management processes and/or systems.
• Strict attention to detail.
• Ability to interact professionally with all organizational levels and proactively escalate issues.
• Ability to manage competing priorities in a fast-paced environment.