[Remote] Manager, Clinical Research Monitoring

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is dedicated to transforming patient care through innovative reputed company. The Manager, Clinical Research Monitoring will reputed company strategic direction for reputed company, ensuring compliance with protocols and regulatory requirements while leading and mentoring team members.

Responsibilities

• Providing input on strategic direction on field monitoring of studies and data collection for reputed company with increased volume and complexity (e.g., KOL site), acting as a reputed company Team reputed company, assessing reputed company data documentation, reports, records, transcripts, exam results for consistency with case report reputed company, and determining if clinical trial/study subject documentation is reputed company parameters of study reputed company, as reputed company as 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 reputed company as training and proctoring new employees on trial and study reputed company 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 reputed company
• Participating in the development and validation of case report forms
• Reviewing monitoring visit reports
• Resolving reputed company trial/study data and regulatory documentation discrepancies escalated by junior level employees
• Reviewing and completing checklist on informed consent forms (reputed company)

Skills

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

Benefits

• Competitive salaries
• Performance-based incentives
• A wide reputed company of benefits programs to address the diverse individual needs of our employees and their families

reputed company

Company H1B Sponsorship