Clinical Compliance Project Manager

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Objective:

To assist in the implementation of compliance and quality within the Clinical Research Department by supporting the management of clinical investigations, audits, vendor qualifications and helping establish department metrics. This role may also assist with ensuring company compliance to GCP regulations, internal procedures, and policies in cooperation with peers.

Responsibilities:

• Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial/activity to identify compliance metrics for tracking and monitoring high-risk vendors.
• Review and evaluate updates to standards including but not limited to ICH, GCP, and ISO to conduct gap assessments to internal SOPs and procedures.
• Act as point of contact for internal clinical mock and external audits, as well as notified body communications.
• Participate as a member of governance teams for assigned product specific studies.
• Assist in setting annual audit schedules for active studies and vendors, in addition to reviewing budgets.
• Manage and/or conduct clinical research external site, vendor audits, vendor qualification, and commercial partner audits in conjunction with QA personnel according to Federal, State, and local regulations,
• Develop audit management plans and audit strategy with clients for ongoing clinical trials. Management includes reviewing audit reports and supporting documents from Clinical Research Organizations (CROs) and independent auditors, as applicable.
• Assist in the development of & implementation of new clinical trial quality/compliance/risk Standard Operating Procedures (SOPs) and systems.
• Drafting and improving work instructions, forms, and templates.
• Perform document record review including protocols, general study files, clinical study reports, monitoring plans, and site-specific study files across product lines.
• Analyze trends, thresholds, and risk impact of quality events.
• Review and approve audit response, evaluate adequacy of corrective and/or preventative actions, and ensure corrective actions are implemented in a timely manner.
• Develop strong relationships with personnel across product lines to provide compliance guidance as needed.
• Identify and escalate significant compliance issues and company risks to leadership.
• Maintain a high level of expertise in applicable regulations and government, industry, and company GCP standards.
• Present GCP, compliance, and FDA BIMO inspection readiness proficiency training on an as needed basis.
• Support global inspection readiness and make recommendations for its improvement.
• Support CAPA and NC owners with appropriate resolutions and quality checks.
• Lead in developing study specific risk mitigation plans and corresponding metrics.
• Assist in the development and management of TMF system
• Ensure compliance with all Federal, State, local, and company regulations, policies, and procedures.
• Ensure a culture of clinical quality compliance
• Use risk-based strategy to prioritize and support clinical trial activities and identify and escalate compliance issues.
• Assist in the development of metrics identifying performance improvements initiatives with clinical trial sites and vendors.

Qualifications:

• BS or MS degree in biological science, epidemiology, engineering, statistics, or other science related field.
• 3-4 years of experience within the medical/biomedical industry

OR

• 5-7 years of relevant medical device and/or quality compliance experience within the medical/biomedical industry.
• Ability to work independently and think outside the box to support a variety of company products.
• Previous experience managing quality and GCP compliance issues preferred.
• Previous experience with vendor audits and vendor qualifications preferred.
• Previous experience with site monitoring and site compliance preferred.
• Previous experience with electronic TMF systems preferred.
• Expert knowledge of international GCP regulations is a plus (FDA, MHRA, PMDA, and ICH).
• Excellent written and oral communication and presentation skills.
• Strong personal leadership skills, as well as strong analytical and critical thinking skills.
• Excellent interpersonal skills and ability to work in a team-based, collaborative environment.
• Demonstrate strength in analytical and strategic assessment of regulatory compliance risks and the ability to articulate potential business impact.
• Ability to independently plan, organize, coordinate, manage and execute assigned tasks and multiple projects.
• Willingness to travel.
• Good understanding of applicable regulations.