Monitoring Oversight Lead (Lead CRA)

Artivion, Inc.; Kennesaw (GA); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Artivion, Inc. in Kennesaw, Georgia, is seeking a Clinical Operations Manager to lead multiple clinical operation project teams. You will ensure compliance with regulations and manage CRAs' daily operations. Ideal candidates have a Bachelor's degree in health sciences, five or more years of CRA experience in a clinical setting, and excellent communication skills. The position offers an opportunity to mentor and support junior clinical team members while overseeing clinical trial management processes.

Qualifikationen

• Five or more years of experience as a CRA in a CRO or medical-device setting, with leadership experience preferred.
• Thorough knowledge of clinical operations, the clinical development process, and the ICH/GCP regulatory environment.
• Ability to serve as a mentor, coach, and trainer for assigned CRAs.

Aufgaben

• Coordinate & manage clinical monitoring activities from site start‑up through database lock.
• Oversee assignment of appropriate project‑specific training for CRAs.
• Conduct qualification, initiation, interim, and close‑out visits and provide visit reports per monitoring guidelines.
• Maintain effective communication between study sites, the clinical team, and the client.

Kenntnisse

Clinical trial management

Leadership

Excellent communication

Critical thinking

Problem-solving

Ausbildung

Bachelor’s Degree in health sciences

Tools

Microsoft Outlook

EDC

CTMS

eTMF

IVRS

Jobbeschreibung

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’s four major product groups are:

• Aortic stent grafts
• Surgical sealants
• On‑X mechanical heart valves
• Implantable cardiac and vascular human tissues

With over 1,400 employees worldwide, Artivion has manufacturing facilities in Atlanta, Georgia; Austin, Texas; and Hechingen, Germany.

Position Objective

To provide direction and leadership to multiple clinical operation project teams. This position ensures each study meets its intended goals, that the team conducts the clinical trial in compliance with state and federal regulations, and emphasizes proactive quality, operational consistency, and CRA performance oversight.

Responsibilities

• Coordinate & manage clinical monitoring activities from site start‑up through database lock.
• Provide day‑to‑day operational management of CRAs to ensure delivery against contracted scope of work.
• Ensure implementation and adherence to SOPs and study‑specific processes by the project team.
• Assist department leadership in identifying training and development needs for CRAs.
• Oversee assignment of appropriate project‑specific training for CRAs.
• Support and/or interface with external vendors and clinical site personnel as needed.
• Assist project management with the development of study tools, presentations, and materials for investigator meetings, site qualification visits, and site initiation visits.
• Provide input on the development of clinical trial documents, including protocols, case report forms, informed consents, monitoring plans, site reference manuals, pharmacy manuals, laboratory manuals, training materials, and site initiation slide presentations.
• Make initial site contact, conduct evaluation visits, and establish relationships with selected trial sites to meet recruitment, quality, and cost targets.
• Assist in supporting regulatory submissions.
• Supervise shipment of study drugs and materials to sites as required.
• Conduct qualification, initiation, interim, and close‑out visits and provide visit reports per monitoring guidelines.
• Co‑monitor study sites with assigned CRAs as required.
• Assist in mentoring and training departmental staff and contribute to development of junior clinical team members.
• Ensure audit readiness by maintaining the eTMF/TMF up to date and reviewing the eTMF at regular intervals.
• Maintain study‑specific tracking tools as needed (via Clinical Trial Management System).
• Liaise with the Safety group in managing serious adverse events and SAE reports, ensuring appropriate action in accordance with policies, SOPs, study requirements, GCP, ICH, and local regulations.
• Provide trial site updates according to study‑specific monitoring guidelines.
• Attend project meetings, teleconferences, and provide monitoring updates.
• Attend and present at investigator meetings.
• Support trial sites in meeting project timelines and proactively inform the PM and team of corrective action, as necessary.
• Assist in preparation for audits and inspections; participate in inspections and respond to any identified issues within the specified timeframe.
• Maintain effective communication between study sites, the clinical team, and the client to ensure trial success.
• Review monitoring visit reports, metrics, protocol deviations, and follow‑up items to identify trends, risks, and compliance issues; summarize findings and support development of corrective and preventative actions (CAPAs).
• Conduct routine oversight activities and targeted quality checks to ensure adequate monitoring and trial conduct.
• Mentor, train, and support CRAs, including onboarding, ongoing development, and performance coaching.

Qualifications

• Bachelor’s Degree required; degrees in health sciences strongly preferred.
• Five or more years of experience as a CRA in a CRO or medical‑device setting, with leadership experience preferred.
• Thorough knowledge of clinical operations, the clinical development process, and the ICH/GCP regulatory environment.
• Ability to serve as a mentor, coach, and trainer for assigned CRAs.
• Excellent oral and written communication skills in English, including presentation skills.
• Proficiency in Microsoft Outlook, Word, Excel, and PowerPoint.
• Experience with EDC, IVRS, CTMS, eTMF, and other clinical project‑management tools.
• Ability to self‑motivate, work as a team player, and work independently.
• Excellent critical‑thinking and problem‑solving skills.