Location: London, UK

Reporting to: Senior Manager, R&D Quality

Orchard Therapeutics is an international biotechnology company dedicated to bringing transformative gene therapies to patients with serious and life-threatening orphan diseases. Created two years ago, it is in an exciting start-up phase where a Quality Assurance professional can have a real impact on the work and foundations that are being created. This role will report to the Senior Manager, Research & Development Quality located in London, England. The Clinical Document Specialist will be responsible for Trial Master (TMF) quality as per GCP/ICH guidelines. The candidate will prepare, process, and track documents received paper and electronic as per project guidelines in a timely manner. The candidate will ensure that documents are scanned, imported, coded and indexed into the (e)Trial Master File and reviewed for quality on an on-going basis. The candidate will assist in periodic audits of external TMFs as well as internal TMF Audits. The ultimate responsibility will be to ensure submission and inspection readiness for the TMF.

• Global responsibility for Trial Master (TMF) quality for sponsor and/or CRO studies.
• Assist in periodic audits of clients TMFs as well as internal TMF audits.

• Prepare, process and track documents received paper and electronic as per project guidelines in timely manner.
• Ensure documents are scanned, imported, coded and indexed into the (e)Trial Master File and reviewed for quality on an ongoing basis.
• Archive all paper files and maintain an ongoing inventory list of all received files as per guidelines in timely manner.
• Provide Electronic Document Publishing support (i.e., scanning, OCR, rendering, bookmarking/linking, document verification and compiling).
• Liaison with internal and regional teams to ensure completeness and quality of documents.
• Maintain and perform Central Files responsibilities and functions.
• Plan and perform periodical quality check of (e)Trial Master Files & the Paper TMF files to identify any filing issues experience by the Clinical Trial Teams to ensure that both (e)Trial Master Files and Paper TMF Files meet internal and external quality standards.
• Support the trial management teams in the preparation, conduct and follow up of internal and/or external audits/inspections.
• Assist in writing and editing SOPs to keep current with industry changes on TMF management, quality and archival.
• Assist in training team members teams on essential documents and regulatory requirements.
• Participate and become an expert in the TMF Reference Model and stay current on regulatory changes.
• Assist in development of Project Timeliness.
• Take a proactive role in learning about clients’ industry, business needs and company culture, educating the project team, identifying new business opportunities and providing a high level of service.
• Monitor and communicate project progress, ensure strict adherence to deadlines and budges and ultimately produce high quality deliverables.
• Responsible to ensure submission and inspection readiness for the TMF.

QUALIFICATIONS

• Document Management
• Proficiency in Adobe Acrobat Professional, ISI Tools, and web-based document indexing, and application. Knowledge of i.e., scanning, extracting, uploading, OCR, rendering, bookmarking/linking, document verification and compiling.
• Previous employment at pharmaceutical company or Contract Research Organization (CRO).
• Experience in collecting, scanning, and coding TMF documentation.
• Knowledge of clinical development phases and processes including GCP and ICP regulations.
• Previous experience overseeing TMF audits, internal and/or regulatory audits.
• Experience in overseeing and training employees on TMF SOPs and regulatory requirements.
• Superior writing and spoken communication skills in English.
• Proficiency in Microsoft Office (Word, Excel, Outlooks., eTMF and eClinical technologies
• Minimum Associate Degree in Science, Preferred BS 4-year college or equivalent.
• Minimum of 3 years of experience in the life sciences industry.
• Multitask in a fast-paced environment
• Work well with people from a variety of different backgrounds and cultures.
• Work independently and as part of a team.
• Take active measures to solve problems and commit to a high level of service.

PROFILE

• Minimum Associate Degree in Science, Preferred BS 4-year college or equivalent.
• Minimum of 3 years of experience in the life sciences industry.
• Multitask in a fast-paced environment
• Work well with people from a variety of different backgrounds and cultures.
• Work independently and as part of a team.
• Take active measures to solve problems and commit to a high level of service.