Reporting to: Director, Clinical Operations & Data Management
Location: London
Orchard Therapeutics, recently acquired by Kyowa Kirin, is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. Orchard has its global headquarters in London and U.S. headquarters in Boston.
Clinical Operations & Data Management sits within Clinical Development at Orchard and is a critical function in all studies to ensure proper planning, conduct, patient safety, and data quality. Orchard’s study delivery model is hybrid outsourcing; Clinical Operations therefore have a responsibility for fostering excellent communications between sponsor, investigator site(s) and vendor(s).
Reporting to the Director Clinical Operations, the Lab Vendor Co-ordinator, Clinical Operations is responsible for overseeing clinical lab logistics for one or more programs, and partners closely with the Study Managers. They will have an important role in tracking subject specimens and managing relationships with multiple laboratory vendors across therapeutic areas, based on business need. This role is critical for ensuring sample shipment and testing oversight and that all vendors meet contractual obligations and Orchard's standards for quality, efficiency, and compliance.
Key Elements and Responsibilities
· Assist in lab vendor selection, qualification and onboarding
- Participate in the evaluation and selection process for lab vendors and coordinate with QA on any required audits
- Initiate New Vendor Process with any new laboratory vendors
· Quote and Budget Management
- Obtain, review, and negotiate quotes from vendors for various laboratory services
- Ensure protocol alignment for contracted services
- Review and approve vendor invoices, ensuring they are aligned with contract terms
· Specimen Management
- Track shipping of subject samples from one facility and/or institution to another
- Provide notification of incoming samples to receiving facility and reconcile samples received
- Assist with query management from laboratory to sites or from third party vendors
· Vendor Management
- Collect laboratory certification in line with applicable industry standards and regulations
- Serve as main point of contact for central laboratories, provide overview of clinical study progress and follow-up on any issues/concerns
- Monitor and evaluate laboratory performance based on contractual obligations and any predefined quality metrics
- Report non-compliance to Orchard Study Manager and/or Director, Clinical Operations
- Manage issues to resolution in collaboration with the Study Manager and/or Bioanalytical specialist as needed
· Continuous Improvement
- Identify opportunities for process improvement and cost savings
- Review and input on necessary SOPs and plans
· Other Duties
- As assigned by Director, Clinical Operations
- Provide support for audit and/or inspection activities
Requirements
Required Skills
· High level of accountability with self and others
· Hands-on approach with a desire to learn
· Team and action-oriented
· Analytical thinking with track record of successful problem-solving
· Ability to work independently and take initiative
· Driven with to achieve continual improvement and strong quality culture, leading to efficient and effective ways of working
· Highly organised with effective written and verbal communication
Education & Experience
· BSc in life sciences
· Minimum of 2 years’ experience in a clinical laboratory, research setting or CRO
· Vendor management experience
