Clinical Research Specialist in Redhill

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 the Clinical Affairs team, you’ll evaluate data to increase access to pioneering technologies for patients in need. You will drive the evidence needed to optimize patient outcomes in collaboration with principal investigators, medical professionals, patient advocacy groups, and regulatory authorities. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit pursues an innovative portfolio of technologies to address unmet clinical needs in patients with mitral and tricuspid heart valve disease.

Responsibilities

• Perform study start-up and conduct activities including ICF review that meet regulatory requirements.
• Create study-specific essential document lists, manage and communicate the status of study progress and activities.
• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge.
• Develop processes to mitigate reoccurrence throughout study phases.
• Conduct in-house and site reviews of documentation and participate in internal and competent authority audits (e.g., FDA, DEKRA, PMDA) to ensure TMF documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations.
• Assess current processes, identify opportunities, and propose solutions to improve process efficiency within and across related functional areas.
• Partner with cross-functional teams (e.g., clinical data management, field teams) on query management, data reviews, and resolution.

Required

• Bachelor’s Degree or equivalent with 3 years of experience in clinical research (site management, clinical project management, monitoring, and/or CRC), including quality assurance/control and regulatory compliance or field monitoring experience in the healthcare industry or equivalent work experience based on Edwards criteria.

Preferred

• Experience in medical devices or regulated industry.
• Experience in electronic data capture.
• Good computer skills (MS Office; clinical systems such as CTMS, eTMF, EDC).
• Demonstrated experience in data analytics and visualization (Excel, PowerBI, Python, etc.).
• Strong written and verbal communication, presentation, interpersonal, and analytical skills.
• Strong problem-solving and critical-thinking abilities.
• Understanding of cardiovascular anatomy, pathology, and physiology or relevant business unit expertise.
• Knowledge of Edwards policies, procedures, and international/domestic medical device regulatory guidelines relevant to clinical protocols.
• Understanding of regulatory submissions, reporting, and audits.
• Ability to manage confidential information with discretion and to balance competing priorities in a fast-paced environment.
• Ability to interact professionally with all organizational levels and build productive internal/external relationships.

Additional Information

Aligning our overall business objectives with performance, Edwards offers competitive salaries, performance-based incentives, and a wide variety of benefits programs.

For California (CA), the base pay range is $87,000 to $123,000 (highly experienced). Pay depends on qualifications, education, and prior experience.

Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Policy: Edwards is committed to protecting patients and healthcare providers. All patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, you must provide proof of vaccination unless a medical or religious accommodation is granted. The vaccination requirement does not apply where prohibited by law.

About Edwards Lifesciences: Edwards Lifesciences is a leading global structural heart innovation company, focused on delivering life-changing innovations through breakthrough technologies, world-class evidence, and partnerships with clinicians and healthcare stakeholders.