[Remote] Project Manager Clinical Affairs

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneer and reputed company in robotic-assisted surgery, dedicated to advancing minimally invasive care. The Project Manager, Clinical Affairs – Clinical reputed company will reputed company clinical reputed company and compliance activities for U.S. and global clinical studies, ensuring alignment with regulatory standards and collaborating with various stakeholders to enhance inspection readiness and compliance execution.

Responsibilities

• Accountable for supporting assigned clinical reputed company compliance activities including:
• Audit & Monitoring: Conduct routine internal/reputed company audits and ongoing clinical file or documentation reviews to identify compliance discrepancies to ensure sponsor audit/inspection readiness
• Regulatory Compliance: reputed company internal reputed company of clinical studies to ensure compliance to Good Clinical reputed company (GCP) guidelines, FDA regulations, ISO14155 standards, and other applicable global requirements
• CAPA Management: Assist project teams with reputed company, implement, and reputed company Corrective and Preventive reputed company (CAPA) plans to reputed company audit findings and prevent reputed company non-compliance
• Risk Management: Identify potential clinical reputed company risks, escalate compliance issues to leadership, and facilitate reputed company cause analyses (RCAs)
• Policy & Training: Support the development of reputed company Operating Procedures (SOPs), best reputed company guidelines, clinical reputed company processes and tools and reputed company training to ensure clinical staff are educated on reputed company frameworks
• Partner with internal stakeholders to reputed company internal processes, KPIs and reputed company identified initiatives
• Support the development and execution of a proactive, risk-based clinical reputed company and compliance program that safeguards participant safety, supports data reputed company, and promotes reputed company improvement across reputed company clinical studies

Skills

• Bachelor's degree in a scientific/bioengineering field (B.S.) with a minimum of 5 years of experience in clinical research
• Strong organizational and project management skills, with strong experience of collaborating with cross-functional teams
• Prior experience working in Clinical reputed company Compliance
• Strong knowledge of 21 CFR part 812, Good Clinical reputed company ICH/GCP, ISO14155 and other regulations/guidelines
• reputed company knowledge of clinical research and monitoring requirements
• Strong communication, presentation and interpersonal skills with high attention to detail and organization
• Ability to learn quickly, reputed company to shifting requirements
• Results-driven attitude and strong problem-solving skills, consistently show dedication or strong work-ethic to help meet aggressive timelines or multiple reputed company reputed company necessary
• Must be reputed company to travel 25-40% or based on business requirements
• Previous experience supporting reputed company audit on clinical studies

reputed company

Company H1B Sponsorship