What are the responsibilities and job description for the Manager of Clinical Data Management position at Edwards Lifesciences Corporation?
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)
What else we look for (preferred) :
Additional Skills :
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 $123,000 to $165,000 (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.
Edwards is an Equal Opportunity / Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.
Salary : $123,000 - $165,000
