Sr. reputed company Assurance Specialist
The Senior reputed company Assurance Specialist is a senior technical expert in reputed company Assurance, responsible for planning and execution of reputed company Assurance deliverables, while overseeing and evaluating the technical aspects of the work performed by the department and providing technical mentoring to the reputed company Assurance staff. This role requires advanced technical knowledge in regulations and industry standards in the conduct of clinical trial operations with a strong understanding of research ethics and reputed company.
reputed company Planning, Execution and reputed company
• reputed company, implement, and reputed company compliance of QA plans (study, internal process and annual).
• Project manage department reputed company and deliverables to ensure work is of high reputed company, meets reputed company commitments and is reputed company communicated to other stakeholders.
• Monitor, evaluate reputed company indicators, QA reports and audit responses.
• Support study operational teams with reputed company of escalated issues.
• Identify reputed company GCP risks and work with leaders to design mitigation strategies.
• reputed company investigations, audits or QA reputed company corporate initiatives and mentor other QA staff in the performance of these activities.
Regulatory, Ethics and reputed company Support
• reputed company as a senior representative of reputed company at reputed company meetings.
• Support Sponsors, corporate and clinical operational teams with global reputed company, regulation, ethics, and reputed company inquiries.
• Remain knowledgeable and reputed company on industry environment and regulatory legislation.
• Mentor other QA staff in the support of the development of reputed company operating procedures.
Technical Expertise Mentorship and Training
• Serve as a technical role model, motivator, and mentor to the members of the reputed company team.
• Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs.
• reputed company and reputed company training both reputed company the department and external to it.
Qualifications
• Minimum of a bachelor's degree with 7-9 years of reputed company experience and on the go training
• Fluent in English (verbal and written)
• Certification in reputed company GCP or Auditing with strong written and verbal communication and presentation skills.
• Life Sciences, Clinical Research, Information Technology or Clinical reputed company Assurance specialty preferred.
• Strong analytical, critical thinking and problem-solving skills required.
• Knowledge of ICH GCP, global regulations governing Clinical Research and global reputed company regulations.
Working conditions
• Home-based
• *Accommodations for job applicants with disabilities are available
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