This is a unique opportunity to join an early-stage product development group, Advanced Technology, focused on developing solutions for patients suffering from heart failure. The candidate will join a competitive, dynamic team playing a pivotal role in the development of clinical strategies bringing new medical devices from concept to human use.
As the Safety Manager you will ensure patient safety in clinical trials by assuring adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), Clinical Event Committee (CEC) Charter, and with EW procedures and ethical standards.
Responsibilities and duties:
- Provide oversight on all safety processes from the site to the CEC to ensure process flow is managed efficiently and effectively, including formulating and recommending process improvement changes.
- Manage and update in-house safety tracking systems for sponsor’s review, complaint reporting, source documents collection, and adjudication process.
- Develop training programs for clinical team knowledge, and mentor team members to optimize application of knowledge and performance.
- Collaborate with Biostatisticians, Clinical Data Managers, CEC and R&D to facilitate appropriate and relevant safety information is delivered on time for final safety review.
- Adverse Event Handling: Review adverse event notifications and Clinical Report Forms received from the investigational sites or in the electronic database to establish critical priorities based on determination of Serious Adverse Event and unanticipated events for, evaluate the need for additional clinical information, and identify and investigate potential inconsistencies from protocol definitions and codes.
- Investigate and evaluate the need for medical records to support further review, adjudication, and reporting.
- Develop narratives from multiple sources of adverse event reporting and/or complaint review forms to facilitate Safety Officer’s and CEC’s (Clinical Events Committee) reviews, in accordance with regulatory requirements, trial safety processes and Edwards’ procedures.
- Other incidental duties, including conducting internal audits and document reviews.
- Travel up to 20%.
- A Bachelor’s degree in a related biological or life science discipline required.
- Bachelors/Masters in Nursing (BSN or MSN) or Medical degree is strongly preferred.
- Clinical research certification is strongly preferred (ACRP or SoCRA clinical coordinator/ CRA certification).
- Minimum 5 years prior hands-on clinical research experience including clinical safety is required, including working:
- With remote monitoring/data capture software strongly preferred.
- In medical devices/drug safety is required.
- Previous management experience required.
- Note: A combination of additional years of related experience and coursework may be considered in lieu of the education requirements.
- Experience with Cardiovascular Medical Device is required; structural heart preferred.
- Understanding of medical device/pharmaceutical regulatory requirements and documents, device accountability and adverse events reporting.
- Ability to communicate and relate well with key opinion leaders and clinical personnel.
- Excellent written and verbal communication skills, presentation skills, interpersonal skills and analytical skills are a must.
- Substantial computer literacy.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 10,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
USA-USA-California - Irvine