Risk Strategy Director - Fixed Term - UK/US/Europe - Remote

Who We Are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

About the role

The Director, Risk-Based Quality Management will provide functional leadership and contribute to the strategic direction of the RBQM team, providing leadership and Subject Matter Expertise in Risk-Based Quality Management, internally within the business, and to Sponsors.

Responsibilities

• Leads the design and development of cross-functional RBQM strategies in support of the development of RFIs and RFPs.
• Provides pre-award risk assessments and SME support to other functional areas, as required.
• Represents the department as required both internally and externally.
• Works cross-functionally across the organization to champion all aspects of Risk-Based Quality Management from Risk Management to Central Monitoring, including the use of Key Risk Indicators, Quality Tolerance Limits, and Central Statistical Monitoring.
• Leads the development and implementation of new processes, trainings, and procedures within the department and provides SME to other departments and functions.
• Leads and develops staff as appropriate and necessary to ensure successful delivery and personal development.
• Serves as leader within the RBQM Department, contributing to the strategic direction and leading change management activities.
• Contributes to the optimal organization design of the team and ensures allocation of staff to deliver on time, budget, and quality.
• Ensures that all operations carried out by department are conducted to applicable regulations, GCP, WCT SOPs and guidelines, and to the requirements of the sponsor.
• Serves as point of escalation for issues both internally and with Sponsors.
• Utilizes metrics on quality and efficiency and feedback from internal and external customers to ensure delivery of RBQM services.
• Participates in internal audits as well as inspections and audits by third parties.
• Ensures Inspection Readiness for risk assessment and centralized monitoring scope.

Requirements

Deep knowledge of Risk Based Quality Management principles, tools, and systems.

Strong leadership, management, and interpersonal skills.

Able to build relationships and work effectively in a matrix organization.

Superior oral and written communication skills including the ability to communicate in English, both orally and in writing.

Excellent judgment and decision-making skills.

Strong organizational skills and negotiation skills and excellent interpersonal skills and problem-solving ability.

Able to represent the department both internally and externally.

Strong financial acumen, including knowledge of project and department budgeting, forecasting, and resource management.

Deep understanding of clinical research principles and processes.

Qualifications

Educated to degree level or equivalent and with a minimum of 10 years relevant experience.

Proven past leadership experience.

Travel required.

Valid current passport.

Benefits

We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide!

For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn.

We are an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.