Senior Specialist, Clinical Research, Critical Care

Becton Dickinson (BD) recently completed the acquisition of the Edwards Critical Care business.  This position is part of the Critical Care division, and as such will become a part of the BD organization in the future.  Critical Care will operate as a separate business unit, called Advanced Patient Monitoring (APM) within BD's medical segment, aligning with BD's smart connected care approach.   BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. If you are invited to interview for this position, a recruiter will provide further details about this exciting transition. Learn more about BD at bd.com 

This role will be onsite at Spectrum Terrace in Irvine, CA.

How you will make an impact:

The Sr. Specialist, Clinical Research- Critical Care will Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements.

• Responsible for study start-up and study conduct activities including ICF review, developing study specific templates and TMF plan, approving and managing study specific essential documents, managing and communicating the status of study progress and activities, and driving resolution of issues encountered with sites during all phases of the study.

• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution.

• Lead the investigation of all discrepancies identified in study documentation reconciliation by applying clinical protocol requirements, GCP knowledge, Edwards SOPs, and appropriate regulations and guidance. Develop and implement processes to mitigate reoccurrence of issues throughout the study.

• Oversee or perform remote or on-site monitoring visits (SQV/SIV/IMV/COV) for assigned studies and other studies as needed.

• Lead in assessing current and new processes, identifying and implementing solutions to improve process efficiency within and across related functional areas

• Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, TUV, PMDA) audits to ensure documents are compliant with Good

• Documentation Practices and Edwards internal SOPs, and US and OUS regulations

• Provide coaching and knowledge transfer to team members

• Prepare materials for meetings (Steering Committee, Investigators, etc.)

What you'll need (Required):

• Bachelor's Degree in in related field, 5 years of previous experience with regulatory documentation for clinical studies

• Experience in Site monitoring, site qualification, and site training

• Ability to travel up to 20%

• Covid Vaccination

What else we look for (Preferred):

• Sponsor experience with clinical trial operations/research

• Experience in Medical device trial

• Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)

• Excellent written and verbal communication skills and interpersonal relationship skills

• Excellent 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 protocols

• Full understanding of regulatory submissions, reporting, and audits

• Understanding of international and domestic medical device regulations and guidance

• Ability to manage confidential information with discretion

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, the base pay range for this position is $103,000 to $146,000 (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.   

Ed