- Title: Clinical Compliance Manager I
- Code: RCI-ABV-00812
- Location: Abbott Park Illinois (IL) 60064
- Posted Date: 08/12/2019
- Duration: 6 Months
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 232
Bachelor’s degree (or equivalent ) is required, typical in nursing or scientific field. An Associate’s degree/R.N. 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
• Person is responsible for the overall assessment of compliance, quality control and/or standards defined for the execution of clinical trail(s); included managing CAPA, supporting process improvement initiatives and preparing/analyzing metrics. Will matrix manage with as signed therapeutic area or functional partners to ensure proper documentation of companys 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 modiciaton as necessary.
• Develops initial interpretation of relevant regulations and guidelines 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/compliance concerns and actively identifies issues that potentially impact evaluable study data, ethical study conduct and ICH compliance and identify potential interventions of solutions to manage the issues.
• GCP exception management in partnership with the business:
- Potential nonconformity
- Planned deviations
• Inspection support
• Provide consultation on ad-hoc compliance questions
• Must have demonstrated a high level of core and technical competencies through management of various aspect of clinical trails (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 (Phases 1-3, 4).