Manager, Clinical Operations

Edwards Lifesciences; Irvine (CA); On-site; USD 121,000 - 171,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA seeks a Senior Manager to lead the Clinical Affairs team, oversee budgets, and manage external vendors. The role drives internal clinical operations, performance metrics, LMS compliance, and TMF quality, while developing staff and providing strategic direction.

The successful candidate will guide cross-functional teams in regulatory compliance, process improvements, and study delivery, collaborating with PMs and investigators in a fast-paced environment.

Qualifications

• Bachelor's degree in related field.
• 8+ years in regulated industry.
• Clinical trial experience with device therapy.
• Strong project management and leadership skills.
• Proficient with CTMS and MS Office.

Responsibilities

• Manage and lead the Clinical Affairs team, including budget duties and external vendors.
• Oversee internal clinical operations, performance metrics, LMS compliance, CTMS quality, and TMF.
• Develop team members' business acumen and coach feedback to staff.
• Provide strategic direction and prioritise work for direct reports.
• Identify and implement clinical process improvements; lead change management.
• Guide site screening, study document review, and collaboration with PMs on deliverables.
• Represent the functional team at Core Team meetings.

Skills

Leadership

Budgeting

Regulatory Knowledge

Communication

Process Improvement

Education

Bachelor's Degree in related field

Tools

CTMS

LMS

Microsoft Office

Job description

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.

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

• Managing and leading a small team within Clinical Affairs including team budget responsibilities and managing outside contractors/vendors. Overseeing the conduct of the internal clinical operations team including management of performance metrics, effectiveness, LMS compliance, CTMS completeness and TMF quality. Developing team members to increase business acumen and functional skills. Collecting performance feedback of assigned staff from cross-functional stakeholders. Providing strategic direction of the internal clinical research team. Assigning and prioritizing work-related assignments to direct reports.
• Facilitating the creation of process training materials for the internal clinical research team. Conducting training for internal clinical operations staff. Leading in the development of work instructions, forms, templates and operational processes. Coordinating and presenting at department team meetings. Managing the on-boarding and off-boarding of assigned staff.
• Identifying, evaluating and implementing clinical process improvement opportunities. Leading change management processes to ensure successful rollout.
• Providing direction and guidance on clinical operations (e.g., site selection, encouraging screening, study document review). In collaboration with the project managers, ensuring team effectively executes project deliverables. Representing the functional team at Core Team meetings.

What you’ll need (Required):

• Bachelor's Degree in related field with related experience.

What else we look for (Preferred):

• 8+ years of related experience working in a regulated industry
• Relevant clinical trial experience in device therapy for heart failure, heart valve disease, cardiac arrhythmias, coronary artery disease, or peripheral vascular disease
• Proven successful project management leadership skills with ability to meet deadlines on multiple projects
• Proficient in Microsoft Office Suite and related tools and systems (e.g., CTMS)
• Proficient facilitation and presentation skills
• Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Ability to work positively through confrontation and/or conflicting ideas
• Extensive understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP E6, ISO14155, 21 CFR 820, Canadian Medical Device Regulation (CMDR), EU MDR)
• Demonstrated skill set to manage assigned team and provide coaching and feedback, including responsibility for all employee actions and partnering with HR on all aspects of employee relations
• Knowledge of financial aspects of study management
• Ability to develop and integrate metrics to quantify study value and progress to the business
• Strict attention to detail
• Ability to interact professionally with all organizational levels and proactively elevate issues to appropriate levels of management
• Ability to excel within a fast-paced and dynamic work environment
• Ability to interact with internal subordinates, other supervisors, external suppliers, vendors, and study investigators
• Service-oriented focus on study site success and responsiveness to site needs
• Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness

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.

For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.