Clinical Quality and Compliance Specialist

7 days ago


Abingdon, United Kingdom Adaptimmune Full time

**Adaptimmune is a leader in the development of T-cell-based therapies for the treatment of cancer and have multiple early and late phase clinical trials in the US and Europe. Our team is driven by a core goal: that together we can change the way certain cancers are treated and bring important new T-cell based therapeutics to patients in need. Our culture fosters inclusivity, trust, the bravery to handle both success and failure, our ability to collaborate and our honesty. It is through this that we find solutions to the most challenging issues we face in our fight against cancer.**

The Clinical Quality and Compliance Specialist provides support to the Clinical Quality and Compliance department and its sub-groups: Trial Master File (TMF) Compliance, Clinical Compliance, and Clinical Quality; performs quality control review of Clinical Trial Records, files Clinical Quality and Compliance records into the TMF, files hard copy records within the Records Room; provides additional support following up outstanding action items.

**Key Responsibilities**
- Performs Quality Control (QC) review of records for consistency, quality, and regulatory compliance.
- Upload Clinical Quality and Compliance records into the TMF.
- Maintenance of records rooms, including supporting filing, scanning, QC, and inventory of paper records
- Assist/lead training across all relevant functional areas on business processes around Clinical Document Management and the Trial Master File, an eTMF system(s).
- Provides support for Inspection Readiness Activities.
- Supports the follow-up of outstanding issue management actions that are pending due (e.g., Corrective and Preventive Actions (CAPAs), deviations, etc.).
- Support the advancement / development of the Clinical Quality and Compliance Program (e.g., Standard Operating Procedure (SOP) review, process improvement initiatives, etc.).
- Additional tasks as required.

**Qualifications & Experience**
- Bachelor’s Degree - preferably in Life Science, or a combination of education and work experience relevant to the role
- Prior experience working for a Sponsor or full-service Contract Research Organization (CRO) in a Good Clinical Practice (GCP) capacity, or a combination of GCP experience and GXP Quality Assurance (QA) experience
- Prior experience with electronic Trial Master File Systems (eTMF)

**Desirable**
- Prior experience supporting TMF Operations or Clinical Operations in support of TMF activities
- Prior experience with Veeva Vault
- Prior experience with clinical systems such as Clinical Trial Management Systems (CTMS), Quality Management Systems (QMS), Learning Management Systems (LMS), Interactive Voice/Web Response System/Interactive Response Technology (IXRS/IRT)
- Experience preparing for and/or participating in regulatory inspections
- GCP related certifications (e.g., SoCRA, SQA-RQAP, etc.)

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