Careers – USA
Job Posting – position in Philadelphia USA office
We are looking for a smart, well trained, disciplined, and experienced Document Specialist who is ready to transition into a dynamic start up environment. We need a team player with clinical trial experience and initiative, with equally strong interpersonal and communication skills. We specialize in T-cell therapeutics for oncology, and have multiple early phase clinical trials on-going across the U.S. While direct experience in biologics or cell and gene therapy is quite valuable, professional accomplishments in other fields are given equal weight. Competitive compensation package is available.
The Document Specialist will work closely with members of Adaptimmune LLC (U.S.) and clinical sites to ensure timely, consistent and quality setup and maintenance, of Trial Master File (TMF) documents for Adaptimmune’s clinical programs. The Document Specialist is responsible for quality control of TMF documents in the TMF system. The Document Specialist will accurately identify and process TMF documents in a timely manner and assist in the remediation of any incomplete, mis-indexed and duplicate records. The Document Specialist will be expected to manage Trial Master File activities from study start up, maintenance, and study completion of various clinical trials.
Adaptimmune is a small biotechnology company and has ample room for performance-based advancement. Domestic and possible occasional international travel is expected. The candidate will report to the Regulatory Compliance Manager at Adaptimmune LLC, and will provide Trial Master File support for on-going clinical studies as assigned. Specific responsibilities are:
1. Provide Trial Master File support to the Regulatory Compliance Manager at Adaptimmune LLC:
Adaptimmune, LLC, Regulatory Compliance Manager, who have hands on experience in the delivery of an inspection-ready electronic Trial Master Files (TMF) and regulatory and compliance processes and program in association with FDA, ICH and ISO guidances. Adaptimmune is subject to a number of regulations stipulated by Food and Drug Administration (FDA) and other regulatory authorities. These regulations enforce strict quality and compliance standards on Adaptimmune. At present, there are five early phase oncology studies on-going at 9 clinical sites in the U.S. Expansion into pivotal/Phase II trials is expected in the next year. In order to effectively manage this workload in a way that will allow the Regulatory Compliance Manager bandwidth to discharge compliance and quality procedures companywide, the Candidate under the direction of the Regulatory Compliance Manager will be responsible for ensuring that the clinical trial documentation is consistent with the Trial Master File specifications, applicable SOPs, ICH/GCP guidelines and other regulatory agencies requirements and that all Trial Master Files are submission/inspection ready.
2. Additional duties
a) Process documents in the eTMF system(s) within specified timelines, based on document criticality/priority
b) Liaise with Clinical Trial Manager and Associate Directors and/or other end users to resolve document related discrepancies and issues.
c) Comply with metrics established for performance tracking and document trends for improvement processes of Trial Master File reviews.
Education, Skills, and Experience
- Minimum of a BA/BS in Life Sciences Degree.
- 2+ years of clinical trial experience in the pharmaceutical industry.
- Experience/knowledge of ICH/GCP documentation requirements
- Records management experience in a highly regulated environment (preferably Clinical Research) or experience working with clinical/medical records
- Must have experience with Document Management Systems
- Candidate must be highly motivated, independent and a self-starter.
The position is 6 months contract with possible extension and can begin as soon as the ideal candidate is identified.
Interested candidates should send a cover letter and CV/resume to:
Heather Harte-Hall, MSc.
Regulatory Compliance Manager
3711 Market Street, 8th Floor