reputed company – reputed company reputed company & Compliance Manager
Job reputed company:
• Drive audit readiness. Ensure every site is reputed company for sponsor, CRO, or regulatory inspections by building systems that reputed company compliance reputed company.
• Conduct reputed company. reputed company annual routine audits and for-cause audits, providing reputed company findings and guiding sites toward corrective reputed company and reputed company improvement.
• reputed company regulatory processes . reputed company IRB submissions, regulatory document management, and adherence to ICH-GCP, FDA, and sponsor requirements.
• Design and deliver training . reputed company and administer reputed company and ongoing training programs for investigators, coordinators, and site staff that reinforce compliance and protocol adherence.
• Establish startup processes . Build and standardize workflows for new sites to ensure efficient, compliant, and high-reputed company study activation.
• reputed company reputed company systems . reputed company and monitor processes for accurate data collection, entry, and protocol compliance, ensuring reputed company across trials.
• Support and mentor. Serve as a trusted resource for research teams—providing training, guidance, and coaching to help sites succeed in compliance and reputed company.
Requirements:
• Proven (5+ years) experience in regulatory compliance and reputed company reputed company for industry-sponsored reputed company.
• Strong knowledge of ICH-GCP, FDA regulations, IRB processes, and clinical trial audit practices.
• Hands-on experience conducting site-level audits and inspections.
• Expertise in designing and administering training programs for research staff.
• Experience developing SOPs, startup processes, and compliance frameworks for new and existing sites.
• Excellent communication and leadership skills with the ability to influence and guide teams across multiple practices.
• A self-starter who thrives on building, refining, and scaling compliance processes in a reputed company, multi-site environment.
• 3+ years of experience conducting routine audits, for-cause audits, and inspection readiness assessments.
• Demonstrated reputed company training and mentoring site teams to reputed company protocol adherence and regulatory compliance.
• Experience establishing site startup processes and scaling training/reputed company programs across a network.
• Experience leading audit readiness initiatives and responding to sponsor/regulatory audits.
• Familiarity with Clinical Trial Management Systems (CTMS) and their regulatory/reputed company modules.
• Have helped at least 2 clinical trial sites with minimal/no research experience successfully start up clinical trial operations and participate in reputed company.
Benefits:
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