Manager of Clinical Data Management

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.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

We are seeking a dedicated Manager of Clinical Data Management to join our team. In this role, you will oversee the strategy, execution, and staffing of clinical data management (CDM) for multiple clinical trials within the Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit. Your expertise in regulatory policies will be crucial in ensuring that CDM processes comply with all relevant guidelines. You will be responsible for delivering high-quality CDM outputs that support our overall Clinical Strategy.

This is a hybrid (Irvine office and remote blend) or onsite role. Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.

How you’ll make an impact:

• Manage a small team of clinical data management subject matter experts to maintain project assignments, set goals and expectations, and provide issue resolution support to direct reports.

• Plan, organize, and coordinates internal and external data management activities to support assigned clinical trials in accordance with regulatory and company guidelines. Works cross functionally to provide support to clinical study projects. successful completion of assigned deliverables.

• Assist in hiring, development and evaluation of direct reports to increase their business acumen and functional knowledge.

• Reviews and develops workflow and work process standards to ensure that data management activities are in compliance with regulatory and company requirements.

• Leads process improvement projects within CDM and across functional areas.

• Writes, revises, reviews, and edits new or existing SOPs, work instructions, forms, and templates as needed.

• In addition to providing management support, the Clinical Data Manager will lead complex clinical studies as assigned in response to business needs. The candidate must establish their subject matter expertise before taking on any people management responsibilities.

• Other duties as assigned by leadership

What you’ll need (required)

• Bachelors degree in related field

• 8 years of relative work experience in clinical data management

• Proficiency in Medidata Rave EDC (Electronic Data Capture)

What else we look for (preferred):

• Master's Degree in related field

• Direct people development experience

• Clinical data management work experience from pharmaceutical, medical device, biotechnology, or CRO organizations

• Strong understanding of Clinical Trial Data management process and experience in EDC platforms, (Medidata Rave, Oracle Clinical EDC system)

• Extensive experience with Medidata Rave, including designing, managing, and optimizing clinical trial databases to ensure data integrity and compliance with regulatory standards

• Proficient in building and managing clinical data dashboards, including designing reports and metrics to track key performance indicators (KPIs), ensuring data accuracy, and providing real-time insights for informed decision-making.

Additional Skills:

• Proven successful project management leadership skills

• Proven expertise in Microsoft Office Suite and related tools and systems

• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Strict attention to d