Manager, Clinical Research Monitoring

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $126k - $178k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🧪 Clinical Research

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Edwards Lifesciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1958

⚕️ Healthcare Insurance

🧬 Biotechnology

Healthcare Insurance • Biotechnology • Medical Devices

Edwards Lifesciences is a global leader in patient-focused medical innovations. The company specializes in heart valve disease solutions, offering products and services such as transcatheter heart valves and mitral and tricuspid technologies, as well as surgical heart valve solutions. Edwards Lifesciences also focuses on critical care technologies including hemodynamic monitoring, remote monitoring, and predictive monitoring. The company conducts clinical research and is committed to improving patient lives through innovative cardiovascular disease solutions, while being a responsible corporate citizen with an emphasis on global corporate giving.

📋 Description

• Providing input on strategic direction on field monitoring of studies and data collection for clinical trials with increased volume and complexity (e.g., KOL site), acting as a Core Team lead • Assessing all data documentation, reports, records, transcripts, exam results for consistency with case report form • Determining if clinical trial/study subject documentation is within parameters of study hypothesis • Monitoring clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements • Participating and contributing to the development of clinical protocols, informed consent forms, and case report forms • Leading in the development of technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, regulatory documentation requirements as well as training and proctoring new employees on trial and study related activities • Acting as a mentor to new or junior level employees • Providing direction and guidance to execute project deliverables in collaboration with project managers • Identifying and evaluating clinical process improvement opportunities • Overseeing clinical trial conduct including management of metrics (e.g., dashboard), compliance, protocol deviations, and data entry cadence • Participating in the development and validation of case report forms • Reviewing monitoring visit reports • Resolving complex trial/study data and regulatory documentation discrepancies escalated by junior level employees • Reviewing and completing checklist on informed consent forms (ICF)

🎯 Requirements

• Bachelor's Degree or equivalent in related field with 8 years of field monitoring, quality assurance/control and regulatory compliance experience or equivalent work experience based on Edwards criteria • Ability to travel up to 75% domestically • Experience working in a medical device or regulated industry (Preferred) • Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) (Preferred) • Proven expertise in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery (Preferred) • Experience with electronic data capture (Preferred) • Excellent written and verbal communication skills including negotiating and relationship management skills (Preferred) • Excellent problem-solving, organizational, analytical and critical thinking skills (Preferred) • Extensive knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies (Preferred) • Extensive understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise (Preferred) • Strong leadership skills and ability to influence change (Preferred) • Ability to manage confidential information with discretion (Preferred) • Strict attention to detail (Preferred) • Ability to interact professionally with all organizational levels (Preferred) • Ability to manage competing priorities in a fast-paced environment (Preferred) • Must be able to work in a team environment, including serving as consultant to management (Preferred) • Ability to interact with suppliers, vendors and/or customers (Preferred)

🏖️ Benefits

• Competitive salaries • Performance-based incentives • Wide variety of benefits programs to address individual needs