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About the Role

Provides expertise on Clinical Data Management activities, planning and leading data management for multiple projects, and developing data management deliverables.

Responsibilities

• Plan and lead Data Management activities for multiple projects (multi-site and multi-cohort) for clinical trials and PMS post commercial trials.
• Conduct project team meetings, establish and maintain project timelines, and manage stakeholder communications.
• Develop Data Management deliverables including data management plans (DMPs), SOPs, work instructions, user training, and associated documents for CDM.
• Identify and evaluate Data Management process improvements and course correction/alignment opportunities.
• Provide direction and guidance to other team members (e.g., CRAs, PMS staff) to execute tactical Data Management initiatives.
• Identify discrepancies in data, investigate, and liaise with Doctors and clinicians to develop solutions.
• Adhere to all company rules and requirements and take adequate control measures in preventing injuries and protecting the environment.

Requirements

• Bachelor's Degree in a related field.
• 8 years of experience in Clinical Data Management (CDM), clinical data entry, or clinical research.
• Experience working with clinical data and systems.
• Proven successful project management skills.
• Proven expertise in Microsoft Office Suite (including advanced Excel) and EDC (Electronic Data Capture) systems.
• Excellent documentation and communication skills.
• Excellent interpersonal relationship skills, including negotiating and relationship management skills with ability to drive achievement of objectives.
• Good English skills.
• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards.
• Extensive understanding of related aspects 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.
• Represents leadership on sections of projects within a specific area interfacing with project managers and Clinical Affairs team.
• Consult in project setting within specific sections of Clinical Data Management area.
• Provides Clinical Data Management leadership to outsourcing partners on a task level.

Skills

• Microsoft Office Suite
• Advanced Excel
• EDC (Electronic Data Capture) systems
• Project management
• Documentation
• Communication
• Interpersonal relationship management
• Negotiating
• Relationship management
• English
• Clinical Data Management
• Data entry
• Clinical research
• Data discrepancy investigation
• Training development

Location

• Global

Work Type

• Full-time

Experience Level

• 8 years

Education Level

• Bachelor's Degree

About the Company

• Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives.
• Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.