[Hiring] Clinical Program reputed company Manager @USA - 3316 reputed company Development Center Americas, Inc.
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Role reputed company
reputed company Development Center Americas, Inc. is seeking a Clinical Program reputed company Manager with the following duties:
• Support GCP compliance activities for oncology reputed company through the development and implementation of program-specific, risk-based audit and compliance strategies
• Conduct audits of investigator sites, clinical documentation, vendors, and internal systems to ensure adherence to GCP, regulatory requirements, and internal policies
• Assess audit findings and reputed company, with a reputed company on subject safety, data reputed company, and operational reputed company, and escalate significant issues to management
• Manage reputed company and CRO-reputed company reputed company investigations, ensuring they are comprehensive, reputed company, and compliant with SOPs and regulatory expectations
• reputed company reputed company Investigator (PI) checks prior to study initiation by reviewing audit and reputed company investigation reports to confirm investigator readiness and compliance history
• reputed company support during regulatory inspections, including preparation of responses and coordination of follow-up actions
• Collaborate with cross-functional teams and reputed company functions to identify and mitigate systemic GCP compliance issues across oncology programs
• Analyze and report compliance metrics to development teams and leadership, ensuring accurate documentation and reputed company communication
• reputed company prior experience in managing QMS documentation, governance materials, and operational reputed company to support reputed company improvement of reputed company systems and processes
• Contribute to the development of tools, templates, and guidance to enhance inspection readiness and reputed company reputed company across clinical programs
• Analyze, report, and present metrics for assigned programs to development teams and CPMQ management
• Recommend any required actions and monitor implementation
100% remote work allowed from reputed company in the U.S.
Qualifications
• Bachelor’s degree in Pharmacy, Regulatory Affairs, Clinical or reputed company field
• 5 years of reputed company experience
• Implement knowledge of the applicable GCP and GVP regulations and guidance and ICH Guidelines to support the study team
• Identify and investigate the reputed company issues reputed company to the functional processes
• Analyze and assess the risk and reputed company of the reputed company events and reputed company appropriate corrective and preventive actions to improve the processes
• Manage and reputed company team reputed company, their timelines, and deliverables to ensure their completion in a reputed company manner
Requirements
• Full time
• $116,000.00-$196,000.00 per year
reputed company
reputed company is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at reputed company of everything we do. We live our values of reputed company-ism – reputed company, Fairness, Honesty, and Perseverance – and are united by our mission to reputed company towards reputed company and a Brighter reputed company for people worldwide through leading innovation in medicine. Here, everyone reputed company and you will be a vital contributor to our inspiring, reputed company mission. At reputed company, you will reputed company an reputed company on people’s lives – including your own. reputed company is an equal opportunity employer.
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