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 Manager driving clinical quality assurance across AbbVie’s global clinical research affiliates. Ensuring regulatory compliance, inspection readiness, audits, and quality-system excellence.
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 country/regional standards
- Lead or collaborate on risk identification and mitigation/control strategies for clinical research and clinical trials
- Review quality and compliance data to support continuous improvement and establish quality measures
- Drive quality strategy across designated countries and region with RDQA AREA personnel
- Manage fit-for-purpose governance and oversight aligned with 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 strategy and provide inspection-readiness support for local and regional Health Authority inspections
- Provide oversight, support, and follow-up for inspection reports and participate in inspections as needed
- Determine need for country/process assessments and audits; conduct audits as required
- 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
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
- At least 3 years in leadership positions involving people and/or initiatives/projects
- Strong understanding of local and global regulatory and legal requirements and regulatory agency perspectives
- Ability to apply strategic risk focus amid evolving global regulations and expectations
- Agile response to unplanned events and changing regulatory requirements and expectations
- Thorough knowledge of quality systems, auditing standards, and quality management
- Strong analytical, organizational, written, oral communication, presentation, negotiation, influencing, and collaboration skills
- Ability to work effectively with business partners at all levels
- Ability to foster cross-functional collaboration and build global and local relationships
- Fluent in additional languages desirable but not required
- Ability to travel as needed in the AREA, up to 35%
Benefits
- Remote work available
- Equal opportunity employment
- Reasonable accommodation for US and Puerto Rico applicants
- Opportunity to work on innovative medicines and solutions addressing serious health issues
- Professional mentoring responsibilities and leadership development through mentoring
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