Senior Clinical Study Programs Lead

Artivion; Kennesaw (GA); On-site; USD 95,000 - 130,000; Full time

Job summary

Artivion, Inc. in the Atlanta area seeks a Clinical Study Leader to manage studies from design through completion. You will serve as SME, coordinate internal teams, sites, and vendors, and ensure timelines and budgets are met.

The role requires oversight of regulatory submissions, IRB/EC requirements, training development, and audit readiness, with domestic and international travel up to 30%.

Qualifications

• SME for clinical study design and execution.
• Development of core clinical documents and study materials.
• Independent management of study activities, timelines, and stakeholder communications.
• Preparation of regulatory submissions and responses as needed.
• Maintain audit readiness and IRB/EC compliance.
• Vendor selection, contracting, and finance interactions.
• Site management including qualification and initiation.
• Development and delivery of team trainings for US operations.
• Collaborate with Quality and Risk Management on study risks.
• Domestic and international travel up to 30%.

Responsibilities

• Lead study design discussions and act as SME for clinical studies.
• Develop CRFs, informed consent, protocols, manuals, and related documents.
• Own study timeline, budgets, and internal/external communications.
• Coordinate regulatory submissions and responses with regulatory bodies.
• Maintain audit readiness and ensure IRB/EC compliance.
• Manage vendor relationships and contracting workflows.
• Oversee site qualification, initiation, and issue resolution.
• Create and deliver trainings for the study team in the US.
• Collaborate with cross-functional teams on milestones and risk mitigation.

Skills

Clinical study design

Vendor management

Regulatory submissions

Budget management

Project coordination

GCP/ICH knowledge

Training development

Cross-functional collaboration

IRB knowledge

Travel up to 30%

Job description

Artivion, Inc. in the Atlanta area seeks a Clinical Study Leader to manage studies from design through completion. You will serve as SME, coordinate internal teams, sites, and vendors, and ensure timelines and budgets are met.

The role requires oversight of regulatory submissions, IRB/EC requirements, training development, and audit readiness, with domestic and international travel up to 30%.