Job Description

Overview

Senior Site Manager (Sr. CRA) Medical Device (Class 3) position with Magenta Medical Ltd. The Elevate System is a multidisciplinary medical device project focused on providing minimally invasive heart support. The role oversees clinical trial sites, ensures regulatory compliance, and supports site management from study start-up through site closure.

Responsibilities

• Serve as the primary liaison between trial sites and sponsor teams, resolving site-related issues.
• Conduct and oversee all aspects of site management, including site start-up activities, IRB submissions, site training, and study conduct.
• Maintain clinical trial documentation in eTMF and CTMS systems.
• Ensure site compliance with protocols, regulations, and GCP/GDP guidelines.
• Support remote monitoring by reviewing site documentation and resolving queries.
• Assist in audits and regulatory inspections, ensuring audit readiness.
• Track and follow up on SAEs, protocol deviations, and safety reporting.
• Provide site staff training on protocol, GCP/GDP compliance, and data entry.
• Collaborate with cross-functional teams including CRO Monitors to ensure smooth study execution.
• Assist in investigator payments, site invoicing, and budget adherence.
• Communicate status information and risks to appropriate stakeholders in a timely manner.
• Support activation phase planning with leadership to expedite site activations and mitigate barriers.
• Assume additional responsibilities on special projects and initiatives as assigned.
• Mentor junior CRAs and study coordinators.
• Other duties as assigned.

Qualifications and Competencies

• Minimum of a Bachelors degree in Life Sciences or related field (MD, RN, MBA, or advanced degrees preferred) required.
• 5+ years of relevant clinical research experience, focusing on site management and clinical trial support required.
• Experience with Class 3 medical devices and/or complex clinical trials Required.
• Strong knowledge of FDA, ICH-GCP, GDP, and global regulations.
• Proficiency in CTMS, eTMF, and other computer systems.
• Strong organizational and communication skills (written and verbal) with the ability to work in a fast-paced start-up environment.
• Lead Site Initiation Visits including site training and completion of a quality visit report.
• Willingness to travel in support of business activities which may require overnight stays.
• Successfully complete vendor credentialing processes at our clinical partner sites which may include background checks, immunizations, and other health and safety screening.

Preferred Qualifications

• Clinical Research Associate certification (CCRA).
• Experience with IRB submissions, FDA inspections and audits.
• Knowledge of risk-based monitoring and site engagement strategies.
• Interventional Cardiology with Cardiac Cath Lab background.
• Recent Cardiac device monitoring experience.
• Possesses the therapeutic knowledge to sufficiently support the role and responsibilities.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research
• Industries
• Medical Equipment Manufacturing

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