Edwards Lifesciences
Manager, Clinical Research Monitoring
USA-Georgia-Remote
Sponsorship not specified$126k-$178kDetected 8 days ago
GCPComplianceExcelProcess ImprovementClinical TrialsClinical ResearchPatient CarePharmacovigilanceMedical DevicesResearchLeadershipCommunicationCollaborationProblem SolvingCritical ThinkingMicrosoft Office
About the role
- We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives.
Responsibilities
- Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Ability to manage confidential information with discretion
- Ability to manage competing priorities in a fast-paced environment
Requirements
- Bachelor's Degree or equivalent in related field with 8 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria.
- Ability to travel up to 75% domestically.
- Experience with electronic data capture
- Must be able to work in a team environment, including serving as consultant to management
Skills
- Imagine how your ideas and expertise can change a patient's life.
- Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated.
- It's our driving force to help patients live longer and healthier lives.
- Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms.
- Providing direction and guidance to execute project deliverables in collaboration with project managers.
- Identifying and evaluating clinical process improvement opportunities.
- Participating in the development and validation of case report forms.
- Reviewing monitoring visit reports.
- Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees.
- Reviewing and completing checklist on informed consent forms (ICF).
Compensation
- The base pay range for this position is $126,000 to $178,000 (highly experienced).
Benefits
- Experience working in a medical device or regulated industry
- Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
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This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.