Senior Specialist, Clinical Research

Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what’s currently possible, and create solutions for patients many years into the future. If you’re an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We’ll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

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, 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:

• As a Senior Specialist, Clinical Research, you will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements

• Execution of study start-up and study conduct activities including ICF review, developing study specific templates and TMF plan, approving and managing study specific essential documents, managing and communicating the status of study progress and activities, and driving resolution of issues encountered with sites during all phases of the study

• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

• Lead the investigation of all discrepancies identified in study documentation reconciliation by applying clinical protocol requirements, GCP knowledge, Edwards SOPs, and appropriate regulations and guidance

• Develop and implement processes to mitigate reoccurrence of issues throughout the study

• Lead in assessing current and new processes, identifying and implementing solutions to improve process efficiency within and across related functional areas

• Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, ANVISA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations

• Provide coaching and knowledge transfer to team members

• Prepare materials for meetings (Steering Committee, Investigators, etc.)

• Other incidental duties

What you'll need (Required):

• Bachelor's Degree in related field Plus 5 years' experience of previous experience with regulatory documentation for clinical studies

• Experience and expertise in site monitoring, site qualification, and site training

• Able to travel to EU, lead/ attend meetings in different time zones

What else we look for (Preferred):

• US East Coast location (home based)

• Cardiac research exposure/ experience 

• Sponsor experience with clinical trial operations/research 

• Medical device trial knowledge/ experience 

• Experience working with teams outside of the United States

• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)

• Full knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols

• Full understanding of regulatory submissions, reporting, and audits; Understanding of international and domestic medical device regulations and guidance

• Excellent written and verbal communication skills and interpersonal relationship skills

• Excellent problem-solving and critical thinking skills

• Ability to interact professionally with all organizational levels

• Ability to manage confidential information with discretion

• Strict attention to detail

• Ability to manage competing priorities