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.
Currently we are looking for strong management consultants, people with a background in delivery of large & complex transformations and change programs, specifically in the Lab Management & Study Management space.
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/or Change Management (not managing change requests) and/or Business Analysis and/or Process Improvement and/or PMO (Chaucer's own PMO).
Specifically, you will:
- Lead and manage a team to support sample management tracking across the conduct of studies.
- Manage a hosted system and the data flows between sites, laboratories and the central system
- Support this effort in 3 ways:
- Study Support
- Work with Clinical senior management to plan and prioritize the effective rollout out of the tracking tool to study teams
- Work with study managers to effectively and seamlessly on-board theirs study to the new system
- Oversee the monitoring of sample collection, processing and analysis
- Track Protocols, Amendments, and ICFs
- Ensure samples are compliant with protocols, amendments, and ICFs
- Identify any study-specific reporting needs for each study team
- Manage sample management study financial costs
- Support exploratory study analysis on retained studies
- System Administration
- Maintain the system
- Process change requests for the system
- Investigate expansion of the system (new modules; new users)
- System training
- Maintain data integrations between systems
- Process Improvement
- Define Sample Management SOPs/WPDs
- Develop standards for laboratory specifications
- Establish corporate data standards for sample inventory tracking
- Champion EDC data standard changes to support sample tracking
- Establish standards for ICFs
Background should include:
- 15+ years of prior business experience, prior consulting experience at a professional services firm a plus
- 10+ years experience in Life Sciences/pharmaceutical/CRO industry in a clinical development organization
- Must have some study conduct experience
- Must have some sample management experience via study conduct or laboratory experience
- Process engineering and design
- 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
- CTMS/CDMS
- Sample Management
- Records Information Management (eRIM; LIMS)
NB: Full Name Chaucer America, Inc. is acting as an Employment Agency in relation to this vacancy
