Manager, Clinical Research Monitoring

This is a fully remote position, open to applicants in United States.

📋 Description

• Offering insights on the strategic direction for field monitoring of studies and data collection for clinical trials that involve increased volume and complexity (e.g., KOL site), serving as a Core Team lead.

• Evaluating all data documentation, reports, records, transcripts, and exam results for alignment with the case report form.

• Assessing whether clinical trial/study subject documentation aligns with the study hypothesis parameters.

• Overseeing clinical trial/study safety, ensuring adherence to protocols, Good Clinical Practices (GCP), and regulatory standards.

• Contributing to the creation of clinical protocols, informed consent forms, and case report forms.

• Leading the development of technical training related to GCPs, protocols, databases, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements, while also training and mentoring new employees in trial and study-related activities.

• Serving as a mentor for new or junior employees.

• Providing guidance and direction to achieve project deliverables in collaboration with project managers.

• Identifying and assessing opportunities for clinical process improvements.

• Supervising clinical trial conduct, including managing metrics (e.g., dashboard), compliance, protocol deviations, and the cadence of data entry.

• Involved in the development and validation of case report forms.

• Reviewing monitoring visit reports.

• Addressing complex trial/study data and regulatory documentation discrepancies raised by junior employees.

• Reviewing and completing checklists for informed consent forms (ICF).

⛳️ Requirements

• Bachelor's Degree or equivalent in a related field, accompanied by 8 years of experience in field monitoring, quality assurance/control, and regulatory compliance, or equivalent work experience as defined by Edwards criteria.

• Willingness to travel up to 75% domestically.

• Experience in a medical device or regulated industry is preferred.

• Clinical research certification (ACRP or SoCRA clinical coordinator / CRA certification) is preferred.

• Demonstrated proficiency in MS Office Suite, including Word, Excel, and Adobe, along with the ability to operate general computer software and office equipment is preferred.

• Familiarity with electronic data capture is preferred.

• Exceptional written and verbal communication skills, including negotiation and relationship management abilities, are preferred.

• Strong problem-solving, organizational, analytical, and critical thinking skills are preferred.

• In-depth knowledge and understanding of Edwards policies, procedures, and both international and domestic medical device regulatory guidelines pertinent to clinical studies are preferred.

• Comprehensive understanding of cardiovascular anatomy, pathology, physiology, or relevant Business Unit expertise is preferred.

• Strong leadership capabilities and the ability to drive change are preferred.

• Capability to handle confidential information with discretion is preferred.

• High attention to detail is preferred.

• Proficient in professional interaction with all organizational levels is preferred.

• Ability to manage competing priorities in a fast-paced environment is preferred.

• Must be capable of working collaboratively in a team environment, including serving as a consultant to management is preferred.

• Ability to engage with suppliers, vendors, and/or customers is preferred.

🏝️ Benefits

• Competitive salaries.

• Performance-based incentives.

• A diverse array of benefits programs tailored to meet individual needs.