Clinical Trial Assistant supporting MRI data, documentation, and site coordination for NeuroRx Research’s neurology clinical trials. Providing administrative and quality - control support to Project Managers.
About the role
- Senior Clinical Quality Assurance Manager overseeing clinical-trial quality, audits, and regulatory readiness. Supporting AbbVie’s development of innovative medicines across designated countries and regions.
Responsibilities
- Support assigned countries and region through implementation and execution of proactive quality-management activities
- Maintain collaborative relationships with RDQA functions supporting clinical research in designated Affiliates
- Establish relationships with clinical-development leaders and staff to advance the AbbVie Quality System and achieve first-pass health-authority approval
- Oversee quality and compliance in a regulated environment under AbbVie policies, procedures, and applicable country and regional standards
- Lead or collaborate on risk identification, mitigation, and control strategies for clinical research and clinical trials
- Establish quality measures and drive quality strategy in designated countries and region
- Manage fit-for-purpose governance and oversight within the One AbbVie Quality System
- Identify trends, root causes, and risks affecting clinical research
- Maintain regulatory preparedness and support Affiliates R&D Management on Quality System health
- Maintain awareness of applicable regulations and develop quality standards for assigned countries and region
- Support supplier visits, audits, and vendor qualifications
- Develop inspection strategies and provide inspection-readiness support for local and regional Health Authority inspections
- Provide oversight, support, follow-up, and inspection-report responses for Health Authority inspections
- Participate in Health Authority inspections as needed
- Determine the need for country/process assessments and audits
- Conduct audits to assess compliance with regulations, guidelines, policies, procedures, and Sponsor requirements
- Communicate audit results orally and in writing
- Review and approve corrective-action plans and audit responses
- Support robust audit and inspection responses through coaching and education
- Mentor AREA Managers, AREA Associates, or line management as an additional lead responsibility
- Report to the RDQA Associate Director or RDQA Global Director, AREA
Requirements
- Bachelor's degree required, preferably in Biology, Nursing, Pharmacy, or another medical science, combined with equivalent technical experience
- 8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or related development functions
- 3 years of experience in leadership positions involving people and/or initiatives/projects
- Strong understanding of local and global regulatory and legal requirements and regulatory-agency approaches
- Ability to maintain a strategic risk focus amid evolving global regulations and expectations
- Thorough knowledge of quality systems, auditing standards, and quality management
- Strong analytical, organizational, written, oral communication, presentation, negotiation, influencing, collaboration, and networking skills
- Ability to work at an experienced level and lead interactions with business partners at all levels
- Ability to foster cross-functional collaboration
- Fluent in additional languages desirable but not required
- Ability to travel as needed in AREA, up to 35%
Benefits
- Employees can work remotely
- Travel as needed in AREA (up to 35%)
- Equal opportunity employment
- Reasonable accommodation for US & Puerto Rico applicants
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