How will you make an impact:
- Support implementation of assigned clinical research projects related to specific products/topics according to internal and external regional requirements, including acquisition of human use approval from Ethics Committees, case report form review, data collection, site monitoring and auditing. Maintain close contact with clinical study site coordinators and physicians who are clinical investigators.
- Monitoring of studies and data collection for clinical trials, assessing all data documentation, reports, records, transcripts and exam results for consistency with the case report form, review compliance with the clinical investigation plan, as well as to monitor clinical trial/study safety, in keeping with protocols, good clinical practices and regulatory requirements. Document all findings in the monitoring visit reports and escalate to study management as appropriate. Support assigned clinical sites throughout the study process to ensure compliance and study deliverables are met.
- Ensure Audit readiness for internal, external and site Audits by conducting reviews, and collecting and maintaining essential documentation (including ethics and governance documentation). Participates in internal and competent authority (e.g., FDA, TGA, Medsafe) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices and align with global study teams, Edwards internal SOPs, and local regulations.
- Partner with cross-functional teams in the US to keep global alignment (e.g., clinical data management, field monitoring, site management operations, safety, data management) to assist with query management, data reviews and resolution. Escalate issues to the relevant functional team and participate actively in project team meetings with accountability for achieving and reporting on agreed clinical milestones and closely collaborate with internal stakeholders to ensure proper project conduct.
- Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas.
- Ensure adverse events and device-related deficiencies are reported to the Sponsor within the required timeframe. Identify product complaints and report in accordance with regulatory and internal requirements.
- Deliver technical training to internal and external stakeholders on GCPs, protocols, database, compliance, device accountability, adverse event reporting, complaint handling, study investigation protocols, amendments and regulatory documentation requirements. Identify and deliver additional training or coaching for allocated investigative sites where non-compliance is identified.
- Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition. Liaise with Compliance and Legal Counsel to create and amend clinical trial agreements.
- Other incidental duties
What you'll need (Required):
- Bachelor's Degree in related field, 3 years experience previous related medical device and /or clinical Required
What else we look for (Preferred):
- Excellent communication and organizational skills
- Proven expertise in MS Office Suite and ability to operate general office machinery
- Good written and verbal communication skills, presentation, and interpersonal relationship skills including negotiating and relationship management skills
- Good problem-solving and critical thinking skills
- Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Skills Required
- Bachelor's Degree in related field
- 3 years experience in medical device and/or clinical research
Edwards Lifesciences Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Edwards Lifesciences and has not been reviewed or approved by Edwards Lifesciences.
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Retirement Support — Retirement programs include a 401(k) match complemented by a separate profit‑sharing contribution. These elements add meaningful long‑term value to total compensation.
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Equity Value & Accessibility — An employee stock purchase plan with a discount and look‑back feature, alongside stock awards for eligible roles, provides notable upside. Program expansions indicate continued accessibility.
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Leave & Time Off Breadth — Time‑off policies include generous PTO, company holidays, and a year‑end holiday shutdown. These offerings enhance work‑life support when available at the site.
Edwards Lifesciences Insights
What We Do
Edwards Lifesciences (NYSE: EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the help of our employees in areas including Clinical Affairs, Quality Engineering, Research & Development, Regulatory Affairs, Sales & Marketing, corporate functions and more. Our roots date back to 1958 when Miles Lowell Edwards, a retired engineer with a background in hydraulics and fuel pump operations, set out to build the first artificial heart. Edwards believed the heart could be mechanized and was encouraged by Dr. Albert Starr to focus on developing an artificial heart valve. After just two years, the first Starr-Edwards mitral valve was developed and successfully placed in a patient. This innovation spawned Edwards Laboratories. Miles’ fascination with healing the heart and helping patients with heart disease stemmed from his own experience with rheumatic fever as a teenager and continues to fuel our patient-first culture today. Today, we are as passionate about providing innovative solutions for people fighting cardiovascular disease as we have ever been. It's our Credo. It takes integrity, collaboration, innovation, and focus. We are leaders in the design and manufacture of tissue replacement heart valves and repair products as well as advanced hemodynamic monitoring. We partner with physicians to innovate products designed to help patients live longer, healthier, and more productive lives. Our work is both rewarding and a privilege. The importance of what we do defines our approach. We work together to create an environment where ideas can flourish and we provide our people with the resources, expertise and support to bring those ideas to life. For our legal terms and trademarks, please visit: https://www.edwards.com/legal/legal-terms
