Associate Analyst, Clinical Device Management

Edwards Lifesciences•Irvine, CA

2d•Onsite

About The Position

The Associate Analyst, Clinical Device Management is part of the Clinical Affairs team supporting clinical evidence generation for Edwards’ Transcatheter Heart Valve business unit. The role focuses on device accountability for clinical trials, including resolving site questions, investigating discrepancies between site and JDE data, training team members and site personnel on accountability processes, and improving trial workflows. The position also partners with Quality and other stakeholders on device-related issues and supports preparation of regulatory reports. This is an onsite position in Irvine, California. The selected candidate must live within a reasonable commuting distance of the Irvine corporate location and be able to commute on required onsite days. Travel of up to 5% may be required for site visits and events.

Requirements

Bachelor’s degree in a related field and 1 year of previous clinical trial management experience, or equivalent work experience based on Edwards’ criteria.
Strong attention to detail.
Strong problem-solving, organizational, analytical, and critical-thinking skills.
Strong written and verbal communication skills.
Strong interpersonal relationship skills.
Good computer skills, including use of the MS Office Suite.
Good understanding of fundamental principles, theories, and concepts relevant to clinical trial management.
Good understanding of investigational device accountability.
Good knowledge of regulatory requirements and documents, including the Code of Federal Regulations, Good Clinical Practices, and Good Documentation Practices.
Good understanding of clinical trial master files (TMFs).
Ability to manage confidential information with discretion.
Ability to interact professionally with all organizational levels and site personnel.
Ability to work in a team environment with the immediate supervisor and other team members.
Ability to build productive internal and external working relationships.
Ability to manage competing priorities in a fast-paced environment.
Ability to travel up to 5% for site visits and events as needed.
Ability to comply with company rules and requirements, including Environmental Health & Safety rules.

Nice To Haves

Experience with ERP software such as JD Edwards, Salesforce, and a Clinical Trial Management System (CTMS).
Ability to partner with stakeholders to manage site inventory and device accountability.
Ability to ensure clinical sites are adequately set up and stocked with trial supplies and to track their lifecycle in related systems or tools.
Ability to organize and archive documents and data in eTMF and/or CTMS in compliance with procedures and regulatory guidelines.
Ability to retrieve, review, and ensure Good Documentation Practice accuracy and completeness of clinical study documents, including quality checks of increased complexity.

Responsibilities

Communicate regularly with sites and field teams to resolve basic queries.
Investigate and analyze discrepancies between site and JDE data on device accountability in collaboration with stakeholders, such as Finance, Customer Service, and Clinical IT.
Train cross-functional team members, including clinical specialists and field monitors, and site personnel on device accountability processes in electronic databases such as Salesforce.
Identify, develop, recommend, and implement basic process development and improvement solutions for trial workflow timelines, including device accountability data.
Partner with Quality to resolve device-related issues.
Compile and analyze accurate data for regulatory reports submitted to regulatory bodies such as the FDA.
Manage inventory and device accountability for sites in partnership with stakeholders.
Help ensure clinical sites are set up and stocked with trial supplies and track their lifecycle in related systems or tools.
Organize and archive documents and data in eTMF and/or CTMS in accordance with internal procedures and regulatory guidelines.
Retrieve, review, and ensure Good Documentation Practice accuracy and completeness of clinical study documents, including quality checks.
Adhere to company rules and requirements, including pandemic protocols and Environmental Health & Safety rules, and take appropriate measures to prevent injuries and pollution.