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.
Key Responsibilities Include:
May 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 assists in making modification as necessary.
Develops initial interpretation of 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.
Takes initiative to resolve problems and mitigate risk.
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 on 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 6+ years of Pharma-related/ clinical research related experience; 2+ 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, demonstrated leadership abilities and problem solving skills.
Demonstration of successful coaching/ mentoring in a matrix environment.
Competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance).
Preferred global exposure from study initiation through study completion in multiple phases of studies (Phase 1-3, 4).
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.