Supervisor II, Clinical Records Management

Edwards Lifesciences • Irvine, CA

1d

About The Position

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. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.

Requirements

• Bachelor’s Degree or equivalent in related field with substantial technical clinical operations knowledge with 2 years of previous related experience or equivalent work experience based on Edwards criteria.

Nice To Haves

• Full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations
• Strong computer skills in Microsoft Office Suite
• Experience with Clinical Systems (e.g., CTMS (Clinical Trial Management System), electronic Trial Master file (e.g., Veeva eTMF)
• Experience with Class II & III medical devices
• Excellent communication and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives
• Full knowledge and understanding of Edwards policies and procedures related to assigned phase within assigned area of responsibility
• Full knowledge and understanding of international regulations of Good Clinical Practice (GCP)
• Full knowledge and understanding of diverse and applicable regulations and standards relevant to medical devices (e.g., 21 CFR Part 11/50/54/56/801/803/806/807/820/812/814/821/822, ISO 14155; ICH E6)
• Full knowledge of clinical trials and regulatory requirements
• Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
• Ability to lead teams, provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Strict attention to detail
• Ability to interact professionally with internal customers and cross functional teams
• Ability to work in a fast-paced environment
• Must be able to work with cross-functional teams as well as with colleagues from other departments within immediate work area
• May represent the organization to outside contacts, e.g., vendors, suppliers, contractors, staffing agencies

Responsibilities

• Supervising employees and overseeing the daily work activities including assessing daily progress within all aspects of the eTMF (electronic trial master file) including accuracy, completeness and compliance of documentation in multiple clinical research trials.
• Leading sections of improvement projects in collaboration with cross-functional teams.
• Providing feedback and/or conducting performance reviews on employees, including resolving performance issues.
• Providing training and improving training plans for assigned and/or cross-functional team(s).
• Gathering data via data reporting and providing basic assessment to management.
• Representing Clinical Records Management and providing subject matter expertise for internal and external audits including follow up corrective actions and effectiveness monitoring under some guidance from management.
• Leading team with production, distribution and tracking of study materials (e.g. study binders and patient recruitment materials) to clinical sites.
• Leading in the development, maintenance and management of internal study training matrices and tracking of respective training records.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees