Edwards Lifesciences Corp Irvine , CA 92606
Edwards has an exciting opportunity in the Transcatheter Mitral and Tricuspid Technologies (TMTT) group, focused on developing minimally-invasive solutions for patients suffering from structural heart disease.
This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease. The candidate will join a fast-paced, dynamic team and the individual who fills it will play a pivotal role in the development of new therapies and devices, from concept through to human use.
The Sr. Specialist, Clinical Safety will assure adverse events are reviewed and handled in accordance with regulatory requirements (FDA, IRB, EC and Other Regulatory Bodies), and with Edwards' procedures and ethical standards to ensure patient safety in clinical trials.
This role is located in Irvine, CA.
ESSENTIAL JOB FUNCTIONS:
Review and assess site reported adverse events (AEs) and other clinical trial data for potential safety issues. Perform thorough review of medical records to ensure proper reporting of events per study protocol and definitions, and identification of unreported events. Differentiate events by assisting Safety Officer in performing assessment of seriousness, relatedness to device and procedure, and expectedness
Generate clinically relevant AE queries in the clinical database in order to obtain missing or discrepant information; follow up with the enrolling sites until complete resolution, if necessary
Identify potential safety trends and escalate to management
Assist with AE/SAE reconciliation prior to clinical trial database closure/lock
Interface with external partners [i.e. Sites, CRO, Clinical Events Committees (CEC), Data Safety Monitoring Board (DSMB)] to provide oversight on all safety processes from the enrolling site to the CEC and DSMB, to ensure process flow is managed efficiently and effectively, including preparation of CEC packets (dossiers).
Prepare medical case narratives for serious adverse events, utilizing clinical background and experience, by integrating case-related information from source documents (to be used for cross functional activities, including, but not limited to regulatory reports and submissions).
Develop Safety training for study sites. Educate and provide training to sites to ensure proper reporting of AE's and adherence to protocol requirements
Represent Clinical Safety as a member of the clinical study team
Actively collaborate in the development of internal Safety trainings to ensure proper education and development of Safety staff
Act as mentor/resource to support staff. When appropriate, perform Quality Control on other team member's work
Assist in development of safety processes, committee charters and other safety related documents
Interface with internal partners (e.g. Regulatory Affairs, Data Management, Complaint Handling), as needed. Assist in review of and/or preparation of safety related sections and associated documentation for clinical and regulatory documents, including clinical study protocols, clinical study reports, annual reports, etc.
Generate and assess internal safety metrics to ensure adherence to internal and external requirements and timelines.
Collaborate with other team members to develop report specifications and content.
Other incidental duties, including occasional participation in internal or external audits, and travel, when required
Bachelor's degree in biological or Lifesciences field
Clinician Background (e.g. RN, Respiratory Therapist, etc.)
5 years of related experience in Clinical Trials and Medical Device Safety
Experience with an ERP software (e.g. JDE) and Patient Tracking system
Knowledge of FDA regulations and ISO standards related to Medical Devices
OTHER SKILLS AND GENERAL EXPECTATIONS:
Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
Excellent written and verbal communication skills and interpersonal relationship skills: ability to write concise descriptive case narratives
Demonstrated problem-solving and critical thinking skills
Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
Full understanding of medical terminology as it relates to clinical safety
Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint and electronic data capturing system (e.g. iMedidata, Oracle)
Ability to manage confidential information with discretion
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations