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Senior Management Consultant - Quality Oversight Lead for Global Clinical Operations

Senior Management Consultant - Quality Oversight Lead for Global Clinical Operations

Job Locations 
US-New Haven, CT

More information about this job


Chaucer is a 30-year-old management consultancy built on pragmatism, collaboration, and taking a hands-on approach to solving our clients’ problems and adding value to their businesses. By drawing on an individual's strengths, creativity and passion, the consulting team is able to produce results that last. Since our MBO in 2014 we have grown a lot as a business, but are able to maintain the same 'family feel' of our earlier days. Our client list boasts some of the world’s most recognizable name brands but we have more opportunities for people to develop and more space for them to carve that path out in a way that suits their development needs.


Our client is approaching an important MHRA inspection and has engaged Chaucer to support inspection readiness activities, including SME coaching, document preparation, system readiness (e.g. TMF, Safety Database, Clinical Data Management).  A selection of high risk areas has been identified as priority in preparing for this inspection and careful project management and oversight is required to ensure this sponsor is prepared. In addition to inspection readiness, some support of day to day quality issue management is required.


To support this effort, we seek strong management consultants, people with a background in delivery of large & complex transformations and change programs, specifically within Global Clinical Operations.


At your level, you will be either managing workstreams or projects, able to stand on your own with clients, but likely still working within teams. Experience would include Project Management and Change Management (not managing change requests), Business Analysis and Process Improvement and PMO (Chaucer's own PMO).

Specifically, you will:

  • Project manage internal and external Stakeholders, vendors, etc. to prepare for upcoming MHRA inspection
  • Coordinate of cross functional representation to prepare and coach on inspection readiness
  • Create process and quality related materials to aid in inspection readiness
  • Manage CAPAs and other GCP quality issues
  • Contribute to the design and implementation of a risk management framework to respond to ICH E6 R2 guidance
  • Understand clinical trial processes and procedures

Background should include:

  • 7+ years of prior business experience, prior consulting experience at a professional services firm a plus
  • 5+ years experience in Life Sciences/pharmaceutical/regulatory environment in a clinical operations setting
  • Experience creating and supporting project management plans
  • Proven success in contributing to a team-oriented environment
  • Proven ability to work creatively and analytically in a problem-solving environment
  • Excellent communication (written and oral) and interpersonal skills required
  • Strong Excel and PowerPoint skills; Visio and other visualization and analytical tools a plus
  • Solid project management skills, PMP a plus
  • MS Project
  • Excel, PowerPoint & Word Ability to integrate into client environments seamlessly


At Chaucer, we are looking for outstanding talent to help support the growth of our Life Sciences Practice. We seek professionals who have demonstrated high academic/professional achievement, leadership, communication skills, and have a strong interest in consulting, with specific expertise or knowledge in the following:

  • Clinical Operations
  • Systems Implementations & Integrations
  • GCP Quality
  • Medical Affairs
  • Product Launches
  • Procurement & Software Licensing
  • Regulatory Affairs
  • Sample Management
  • Records Information Management (eRIM; LIMS)





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