Global Clinical Trials Associate Project Manager

REVA Medical, LLC.; San Diego (CA); On-site; USD 70,000 - 85,000; Full time

Job summary

REVA Medical, LLC in San Diego, California, is seeking an Associate Project Manager, Clinical Affairs to support the operation and execution of domestic and international clinical trials for implantable devices.

You will assist in site management, data collection, TMF readiness, regulatory submissions, and coordination with CROs, labs, and ethics committees, with travel up to 25-50% as needed.

Qualifications

• Bachelor's degree or equivalent experience.
• Minimum 5 years medical device clinical trial experience.
• Prior experience with Class III implantable devices; peripheral artery disease product and clinical procedure experience.
• Ability to evaluate and have a basic understanding of peripheral angiograms and duplex ultrasounds.

Responsibilities

• Assist in management of clinical investigator sites, CROs, suppliers, trial support staff and data management resources to execute clinical research plans.
• Ensure initiation, development, implementation, and training of clinical sites to maintain data integrity.
• Monitor study data and regulatory binders at assigned sites.
• Oversee device accountability including shipments, returns and tracking across sites.
• Coordinate imaging submissions and tracking with core lab and sites.
• Coordinate with Safety Board core lab for adverse event documentation for meetings.
• Assist in Trial Master File population and audit readiness.
• Provide input to study protocols and related documents.
• Coordinate with ethics committees/IRBs for submissions, including international CRO interfaces.
• Assist in ensuring trial execution, enrollment, and data analysis within timelines.
• Support mock and regulatory audits at sponsor and site level.

Skills

Communication

MS Office

Project coordination

Organizational skills

Education

Bachelor's degree

Job description

REVA Medical, LLC in San Diego, California, is seeking an Associate Project Manager, Clinical Affairs to support the operation and execution of domestic and international clinical trials for implantable devices.

You will assist in site management, data collection, TMF readiness, regulatory submissions, and coordination with CROs, labs, and ethics committees, with travel up to 25-50% as needed.