Clinical Research Project Manager

Artivion Careers•Kennesaw, GA

56d

About The Position

To support the successful execution of global clinical trials by ensuring regulatory compliance, managing site and vendor activities, maintaining data integrity, and contributing to high-quality clinical documentation. This role advances the development of innovative surgical implants for complex heart disease while collaborating cross-functionally and upholding international standards for patient safety and study quality.

Requirements

Bachelor’s degree in biological science, engineering, or another science-related field
Minimum 2 years’ experience planning and executing clinical research studies [or] relevant experience, or advanced degree with 1 years’ experience
Experience overseeing multicenter investigational (e.g. IDE/ pre-CE) studies
Demonstrate project management, critical thinking, and communication skills
Proficient knowledge of medical terminology.
Proficiency in MS Office applications: Excel, PowerPoint and Word, Project (or similar scheduling software), project management techniques and tools; and web-based applications

Responsibilities

Supports regulatory submissions to competent authorities.
May act as a site manager, and may provide site training.
Interacts with sites in accordance with local law, standards, and regulations.
Participates in vendor selection process.
Works with vendor on contracts.
Manages invoices.
Collaborates on core clinical documents.
Represents the core clinical documents and study processes to participating sites in the context of Site Regulatory Binders.
Executes/supports clinical investigators with preparation and submission of required documentation to Institutional Review Boards (IRBs)/Ethics Committee (EC) for approval.
Ensures maintenance of IRB/EC approval throughout the duration of the study.
Provides training to clinical investigators and study personnel regarding protocol requirements, data collection and reporting requirements as necessary.
Assists with developing Health Care Provider (HCP) presentations.
May engage with cross functional teams.
Facilitates queries for all missing or inaccurate data.
Ensures that data changes are properly implemented and captured in the database or data system.
Assists in the evaluation and analysis of clinical trial data.
Disseminates publications to sites as necessary.
Review clinical reports and conduct quality and consistency checks for regulatory submission and/or scientific publication.
Learn the function and clinical applications of a surgical implant which treats complex heart disease conditions, understand the indication, safety, and performance objectives and parameters and ensure consistency across multiple clinical documents.
Contribute to EU Medical Device Regulation processes and documentation generation and support submissions to Notified Bodies.
Support ongoing Post-Market Surveillance and Quality Assurance activities
Ability to travel domestically and internationally up to 30% of the time.