Standards and Compliance Manager II

Job Description

• 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)

• Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
• Travel: Yes, 5 % of the Time
• Job Type: Experienced
• Schedule: Full-time
• Job Level Code: M