Manager responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trial(s); including managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics.
Will have direct reports and will matrix manage with assigned therapeutic area or functional partners to ensure proper documentation of AbbVie procedures, implementation of process changes, ensure compliance and/or execution on timelines and quality deliverables.
Is aware of both internal and external business environments, assesses impact on the processes for clinical study execution and makes modification as necessary.
Interprets relevant regulations and guidelines and act as a SME for Clinical Operations. Assist clinical teams with inspections, audit responses and consult on root cause analysis, as required.
Independently takes initiative to resolve problems and mitigate risk. Escalate significant issues to management.
•Responsible for compliance with applicable Corporate and Divisional policies and procedures.
Provides management of clinical compliance, quality and standards projects within Clinical Operations; prepares key performance indicators.
Provides input new/updates to SOPs, guidelines, work instructions as well as make initial gap assessment of impact of new regulations.
Effectively communicates project progress/ compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions or solutions to manage the issues.
Bachelor’s degree (or equivalent ex-US) is required, typically in nursing or scientific field. An Associate’s degree/R.N. (or equivalent ex-US) with relevant experience is acceptable.
Must have 7+ years of Pharma-related/ clinical research related experience; 3+ years of experience preferably with clinical research, regulatory, compliance and/or quality control.
Must have demonstrated a high level of core and technical competencies through management of various aspects of clinical trials (e.g., audits, study oversight, SOP development, quality assessments).
Possesses good communication skills and demonstrated leadership abilities and problem solving skills.
Demonstration of successful coaching/ mentoring in a matrix environment; direct people management preferred.
Considered a Subject Matter Expert and competent in the application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
Experience with global studies from initiation through study completion/primary data analysis and/or in multiple phases of studies (Phase 1-3, 4)
Key Leadership Competencies:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance
Learns, fast, grasps the 'essence' and can change the course quickly where indicated
Raises the bar and is never satisfied with the status quo
Creates a learning environment, open to suggestions and experimentation for improvement
Embraces the ideas of others, nurtures innovation and manages innovation to reality
At AbbVie, we have the expertise of a proven pharmaceutical leader and the focus and passion of an entrepreneur and innovator. The result is something rare in health care today – a global biopharmaceutical company that has the ability to discover and advance innovative therapies and meet the health needs of people and societies around the globe.