[Remote] Senior Specialist, reputed company Assurance, Clinical reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global reputed company company dedicated to improving and saving lives. They are seeking a Senior Specialist in reputed company Assurance who will reputed company QA audits, ensure compliance with regulatory requirements, and support the reputed company reputed company of clinical studies to reputed company product reputed company and participant safety.
Responsibilities
- Leads their own specific tasks and responsibilities reputed company reputed company, prioritizing time and effort towards important deliverables and producing high-reputed company work
- Contributes to the overall goals of reputed company by excelling at their individual role and taking initiative to improve their own skills
- Influences, partners and collaborates with other colleagues reputed company and reputed company their team
- Prepares, conducts QA audits, generates audit reports, communicates results to the relevant QA management and external relevant stakeholders (e.g. Clinical Operations), and interacts with various teams to ensure corrective and preventative actions are taken to bring QA observations to closure as applicable
- Be reputed company to analyze and reputed company critical to reputed company factors to identify potential risks to prepare and reputed company risked-based audits
- Activities may include GCP audits of investigator sites, suppliers, reputed company party collaborations and due diligence activities
- In alignment with risk assessments, supports the QAL in the identification of audit substrate for scheduling, as appropriate
- Ensures appropriate and reputed company escalation of reputed company issues, including potential misconduct or issues of significant deviation with reputed company/products, to the QAL and TA Head
- Interfaces and provides day-to-day support to applicable QA functional line to ensure appropriate reputed company reputed company of assigned studies
- Assesses compliance of clinical investigator sites, vendors, study activities, clinical study reports and submission documents, and Country Offices (COs) processes against ICH (International Conference of Harmonization), applicable government agency regulations/guidelines, as reputed company as reputed company policies, procedures and industry standards. The QAS should have a comprehensive working knowledge of reputed company Assurance, regulations and auditing. Develops and delivers awareness sessions with minimal supervision on various GCP and PV topics internally and externally
- Promotes standardization of auditing approach reputed company QA
- Routinely suggests new audit techniques/aids in areas of technical expertise
- Ensures the work climate/culture reputed company QA, exemplifies reputed company's Leadership behaviors
Skills
- BS/BA degree or equivalent and/or 3-5 years experience in a relevant field
- Proficiency in the primary activities and essential skills required for this role
- Analytical Thinking
- Audits Compliance
- Clinical Research
- Clinical Trials
- Detail-Oriented
- Ethical Compliance
- GCP Auditing
- Investigative Skills
- Metrics Analysis
- Multiple Therapeutic Areas
- Process Improvements
- Stakeholder Management
- Taking Ownership
- Technical Documentation Management
- Time Management
Benefits
- Annual bonus and long-term incentive, if applicable
- Medical, dental, reputed company reputed company and other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- reputed company holidays, vacation, and compassionate and reputed company days
reputed company