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About the Role
Edwards Lifesciences is a leading global structural heart innovation company dedicated to improving patient lives. This Data Management position offers a unique career opportunity within the trans catheter heart valve (THV) business unit, focusing on clinical data management strategy, execution, and staffing for multiple clinical trials.
Responsibilities
- Manage a small team of clinical data management SMEs, setting goals and providing support.
- Lead Data Management activities for multiple clinical and post-market surveillance projects, ensuring successful completion.
- Develop Data Management deliverables including DMPs, SOPs, and user training documents.
- Identify and evaluate Data Management process improvements and opportunities for course correction.
- Provide direction and guidance to other team members for executing tactical Data Management initiatives.
- Identify data discrepancies, investigate, and liaise with clinicians to resolve issues.
- Perform other incidental duties as required.
Requirements
- Proven successful project management skills.
- Expertise in Microsoft Office Suite (including advanced Excel) and EDC systems.
- Excellent documentation, communication, and interpersonal relationship skills.
- Good English skills.
- Extensive knowledge of own area within the organization and contribution to new concepts.
- Extensive understanding of related Clinical Data Management processes and/or systems.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels and escalate issues.
- Ability to manage competing priorities in a fast-paced environment.
- Represents leadership on project sections and interfaces with project managers and Clinical Affairs.
- Consults in project settings within specific Clinical Data Management areas.
- Provides Clinical Data Management leadership to outsourcing partners.
- Adheres to all company rules and requirements and takes adequate control measures for safety and environmental protection.
Skills
- Clinical Data Management (CDM)
- Clinical data entry
- Clinical research
- Project management
- Microsoft Office Suite
- Advanced Excel
- EDC (Electronic Data Capture) systems
- Documentation
- Communication
- Interpersonal relationship skills
- Negotiating
- Relationship management
- English
- Leadership
Location
- Global
Work Type
- Full-time
Experience Level
- 8 years of experience in Clinical Data Management (CDM), clinical data entry, or clinical research
Education Level
- Bachelor's Degree in a related field
About the Company
- Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.
- With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs.