Director, Quality Risk Management Oversight
A career at Covance provides our employees the unrivaled chance to create an immediate impact and difference in our patient’s lives. Joining Covance will offer a rewarding career, a chance to work in a high-energy & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting.
Our mission is to help our clients bring the miracles of medicine to market sooner -- join us for your next career move.
Essential Position Duties:
- Ensure the CPS and CDS organization understands ICH / GCP guidance as well as local regulatory requirements as it relates to risk management
- Develop and maintain collaborative working relationships between Clinical Quality Assurance, CRUs and Phase I-IV businesses, across all functions within the operational organization
- Standardize CRU approaches to risk management to promote workable solutions to proactively pre-identify identify risk and ensure working standards are appropriately implemented, and if necessary, modified to manage risk
- Ensure organizational consistency of delivery against Covance related Risk Management Controlled Documents
- Ownership for the development and maintenance of the annual Quality Risk Management (QRM) Oversight Plan
- Ensure alignment of QRM across staff, processes and technology across business units and functional groups (e.g. CRUs, PM CoE, Central Monitoring, Xcellerate® Suite, etc.)
- Establish an ongoing process to evaluate the QRM processes in support of Covance’s continuous improvement efforts; communicate results to management and functional leaders as appropriate
- Partner with the Regulatory Intelligence organization to ensure that Covance Controlled Documents are compliant to health authority regulations for risk management pertaining to the conduct of clinical trials
- Implement standard communication and education across all global regions to obtain and maintain desired state. Evaluate effectiveness on an ongoing basis
- Support business development activities through provision of input into the sales strategy and delivery
- Establish and maintain relationships within and/or outside the organization to broaden business knowledge and trends