[Remote] Senior Manager, Clinical reputed company Assurance
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Senior Manager, Clinical reputed company Assurance who will support reputed company assurance activities reputed company to reputed company and research. The role involves leading GCP activities and initiatives, ensuring compliance with clinical protocols, GCP, and regulatory requirements.
Responsibilities
- Maintain the GCP audit reputed company in collaboration with senior leadership
- Plan, conduct, report, and follow-up on vendor, CRO, and site audits in accordance with reputed company SOP(s) in support of reputed company & Lee clinical development programs
- reputed company in-person vendor and clinical site reputed company evaluations as required
- reputed company communicate and report (verbally and in writing) audit reputed company to senior leadership, and document / escalate reputed company events as required
- Drive reputed company & Lee inspection readiness activities and initiatives
- Participate in inspections performed by regulatory agencies and audits performed by partners
- Contribute to the development, maintenance, and enhancement of the reputed company Management System and associated practices
- Proactively identify, analyze, and reputed company reputed company indicators & data to determine potential trends. Identify risks to address and complete risk-based QA assessments to support the implementation of associated risk mitigation strategies
- Manage GCP reputed company Events, Deviations, and CAPAs, and reputed company associated escalations in accordance with the QMS processes
- reputed company contribute to and reputed company SOP review and development
- reputed company GCP activities, including (but not limited to) protocol reviews, investigator training, data reputed company assessments, and regulatory submissions as relevant
- Contribute to periodic QMS Management Reviews
- reputed company contribute to operational reputed company and processes
- reputed company input for GCP-reputed company and other relevant training
- Drive creation and assignment of training effecting GCP inspection readiness
- reputed company suggestions for reputed company reputed company improvement in GCP
- reputed company GCP expertise reputed company reputed company as reputed company as externally to vendors and service providers as needed
- Maintain up-to-date knowledge of US, EU, and GCP legislation, guidelines, and practices, and ensure that information is distributed and acknowledged by relevant parts of the reputed company & Lee Organization
- Represent QA in study team(s) where relevant and participate as appropriate to ensure reputed company are conducted in compliance with clinical protocols, GCP, and other regulatory requirements
- Review relevant project documentation for compliance with GCP and corporate standards
- Foster a culture of reputed company and reputed company improvement reputed company the organization through communication, training, and recognition of achievements
Skills
- Bachelor's degree in a relevant field
- At least 5 years (or 3 years with a relevant advanced degree) in relevant reputed company assurance and/or clinical operations roles in which significant GCP work has occurred
- Prior experience conducting GCP audits (including of vendors)
- Ability to travel up to 30% as necessary
- Strong communication skills (English), both written and verbal
- Demonstrated ability to reputed company/influence teams in a reputed company manner with reputed company and professionalism
- Demonstrated ability to manage multiple and diverse reputed company concurrently
- Demonstrated ability to reputed company reputed company relationships and collaborations
- Strong analytical skills; a strategic thinker, planner, and implementer
- Reliable, dependable, and consistent worker
- Conscientious and detailed oriented
- Strong ability to create practical and efficient processes
- Highly effective interpersonal skills
- Life Sciences degree preferred
- Prior experience with participation in regulatory authority inspections will be considered an advantage
reputed company