Associate Director, Risk-Based Quality Management (US/Remote)

Location: North Carolina, United States

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Requisition Number: 3567

Position Title: Associate Director Risk-Based Quality Management

External Description:

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:

  • Tasks may include but are not limited to:
  • Leads the design and development of cross functional RBQM strategies in support of development of RFIs and RFPs. Provides risk assessments pre-award and provides SME 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.
  • Lead the development of training for department and business, as required
  • Lead and develop 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 to time, budget, and quality.
  • Lead the development and implementation of new processes and procedures within the department and provides SME to other departments and functions.
  • Ensure 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.
  • Utilize metrics on quality and efficiency and feedback from internal and external customers to ensure delivery of RBQM services.
  • Participate in internal audits as well as inspections and audits by third parties. Ensure that recommendations are addressed and applicable actions follow-up to completion.


OTHER SKILLS AND ABILITIES:

  • 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.
  • Strong organizational skills and negotiation skills.
  • Excellent interpersonal skills and problem-solving ability.
  • Excellent judgment and decision-making skills.
  • 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 process.


REQUIREMENTS:

  • Educated to degree level or equivalent and with a minimum of 10 years relevant experience
  • Skill sets and proven performance in equivalent to the above that includes experience in RBQM 
  • Excellent written and spoken English 
  • Proven past leadership experience 
  • Travel required 
  • Valid current passport

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Employment Type: Regular

Community / Marketing Title: Associate Director, Risk-Based Quality Management (US/Remote)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

Location_formattedLocationLong: Research Triangle Park, North Carolina US

CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.

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