Associate Analyst, Clinical Device Management

Edwards Lifesciences • Irvine, CA

4d • $59,000 - $83,000 • Onsite

About The Position

The Associate Analyst, Clinical Device Management is part of the Clinical Affairs team supporting the Transcatheter Heart Valve business unit. The role helps maintain accurate investigational device accountability and clinical trial data, working with clinical sites, field teams, internal stakeholders, and Quality. Responsibilities include resolving data discrepancies, training colleagues and site personnel on accountability processes, supporting process improvements, and compiling data for regulatory reports. This is an onsite position in Irvine, California; the selected candidate must live within a reasonable commuting distance 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 one year of previous clinical trial management experience, or equivalent work experience based on Edwards’ criteria.
• Strict 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.
• Understanding of fundamental principles, theories, and concepts relevant to clinical trial management.
• Understanding of investigational device accountability.
• Knowledge of regulatory requirements and documents, such as the Code of Federal Regulations, Good Clinical Practices, and Good Documentation Practices.
• 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.
• Adhere to company rules and requirements, including Environmental Health & Safety rules, and take adequate control measures to prevent injuries and pollution and protect the environment.

Nice To Haves

• Experience with ERP software such as JD Edwards, Salesforce, and a Clinical Trial Management System (CTMS).

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.
• Provide training on device accountability processes within an electronic database, such as Salesforce, for cross-functional team members and site personnel.
• 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.
• Ensure clinical sites are set up and stocked with trial supplies, and track their lifecycle in related systems or tools under general supervision.
• Organize and archive documents and data in eTMF and/or CTMS in compliance with internal procedures and regulatory guidelines.
• Retrieve, review, and ensure the GDP accuracy and completeness of clinical study documents, and perform quality checks of increased complexity.
• Manage competing priorities in a fast-paced environment.
• Follow company rules and requirements, including applicable pandemic protocols and Environmental Health & Safety rules, and take appropriate measures to prevent injury and pollution and protect the environment.
• Perform other incidental duties.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address employees’ and their families’ diverse individual needs

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level