Job description

Senior Clinical Research Specialist (Remote), Transcatheter Mitral & Tricuspid Therapies (TMTT)

This is an exciting opportunity for you to join a team boldly designing transcatheter mitral and tricuspid therapies from the ground up. Edwards’ Transcatheter Mitral and Tricuspid Therapies team is deeply dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives around the world.

The Senior Clinical Research Specialist will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

Key Responsibilities:

• Responsible for 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, PMDA) 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

Minimum Education and Experience:
Bachelor's Degree, required

5 years' of medical device/sponsor/CRO, industry work experience with regulatory documentation for clinical studies- specifically clinical trial documentation experience, required

Experience in clinical trial execution, required

Experience in site monitoring, site qualification, and site training, required

Ability to travel up to 10% for quarterly meetings in Irvine, CA, required
Preferred Qualifications- in addition to meeting minimum requirements, it would be nice to have the following:

Experience in compliance, or auditing, or clinical quality

Experience with Veeva Vault, SharePoint, PowerPoint, Excel

Clinical Research SOPs

Additional Skills:

• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred
• Excellent written and verbal communication skills and interpersonal relationship skills
• Excellent problem-solving and critical thinking skills
• Full knowledge and understanding of Edwards 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
• Ability to manage confidential information with discretion
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• 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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

The base pay range for this position is $101,000 to $140,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., geographic location, qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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