Hybrid Senior Manager, Clinical Quality Risk Management

at OneTrust

• Job title: Senior Manager, Clinical Quality Risk Management
• Job type: Full Time
• Experience level: Senior
• Salary: $122,000 - $212,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, United States

About the role

• Sr. Manager overseeing Clinical Quality Risk Management for MedTech's Surgery Business. This role involves clinical quality risk management, compliance guidance and cross-functional collaboration.

Responsibilities

• The Sr. Manager, Clinical Quality Risk Management Lead for Surgery advances the Clinical Quality Risk Management (CQRM) objective, overseeing a robust GxP Quality Management System.
• Oversees the overall clinical quality risk management of the Surgery MedTech Business.
• Works across teams to ensure the coordination of the identification, assessment, and mitigation of clinical quality risks that could have an impact on trial data integrity, patient rights, safety, or well-being.
• Oversees the execution of data-driven, risk-based trial and program oversight activities that deliver quality in the execution of clinical trial programs, compliance with regulatory requirements and internal procedures, and that there is a continued state of inspection readiness.
• Develops and ensures a consistent interpretation of issues that require quality investigations.
• Provides guidance for significant quality issues per corporate standards and escalates SQI to senior R&D and Quality & Compliance management.

Requirements

• BA/BSc or equivalent (Scientific, medical, or related discipline) is required
• A minimum of 10 years of experience working in the healthcare or regulated industry (MedTech, pharmaceutical industry, contract research organization and/or healthcare/hospital system, health authority, etc.)
• Excellent interpersonal, oral, and written communication skills
• Proven strong Good Clinical Practices quality and/or clinical trials experience
• Experience collaborating in a cross-functional team environment
• Flexibility to respond to changing business needs
• Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures
• Proficiency in Microsoft Office Applications
• Available for 25% domestic and international travel

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year