Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team in Edwards Lifesciences, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.
How you'll make an impact:
* Perform routine analysis and contribute to activities and projects related to clinical trial payments, contract and budget development, and preparation of analytics and reports.
* Analyze patient data in clinical CRFs (Case Review Form) to determine alignment to protocol requirements.
* Collaborate with manager and/or team members to evaluate and carry out process design and improvements.
* Interact with global HCPs, clinical trial sites, and vendors as well as internal functions and management to resolve inquiries, including reconciliations, analytics, and other ad hoc requests.
* Monitor and evaluate post-process implementation performance and implement changes if necessary. Provide awareness to team members/management.
* Other incidental duties
What you’ll need (Required):
* Bachelor's Degree in a related field and at least 1 year experience in finance, analytics, payments, and/or budget in a clinical setting.
What else we look for (Preferred):
* Good knowledge and understanding of policies, procedures, and guidelines relevant to data analytics within clinical payments.
* Understanding of contracts and negotiations.
* Good knowledge of concepts of clinical research and device development.
* Good understanding of quantitative methodologies, techniques, and tools.
* Excellent level of English.
* Proficiency in MS Office Suite applications.
* Strong written and verbal communication skills and interpersonal relationship skills.
* Good problem-solving, organizational, analytical, and critical thinking skills.
* Knowledge of local and global regulations (e.g., AdvaMed, Anti-Kickback, Anti-Bribery, Sunshine Act).
* Understanding of Good Clinical Practices, ICH guidelines, AdvaMed code, clinical research ethics, and patient privacy laws (plus applicable local regulations).
* Knowledge of clinical study protocols, clinical trial materials, and clinical costs.
* Experience in the medical device industry is preferred.
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