Scancell is a cancer vaccine company currently developing novel treatments for hard to treat cancers. Founded in 1997 as a spin-out from the University of Nottingham, it employs over twenty staff, with research scientists located in Nottingham and some managerial, development and administrative staff in Oxford.
The Document Manager will play a pivotal role in ensuring document control within the Company. As this is a new position, the post holder will be responsible for the development, execution and maintenance of a document management plan and quality control activities to align with the Company’s Quality Management System.
The post holder will ensure the security, accessibility and proper distribution of company documentation, which may be scientific, clinical, regulatory, health and safety related, legal, financial or commercial in nature. You will be based at the company’s premises on the Oxford Science Park and will additionally provide remote support and/or training to other sites with occasional travel being required. You will be a key member of staff who will manage your own workload on a day-to-day basis and report to the Senior Project Manager.
This position is currently part-time (0.6FTE) which will allow for flexible working and comes with a comprehensive benefits package and competitive remuneration.
• Lead in the development, execution and maintenance of the Company’s document management plan
• Develop, implement and maintain systems to track key documentation throughout the document life cycle.
Key documentation will include (but will not be limited to) Scancell’s Standard Operating Procedures (SOPs), GDPR, templates and forms, staff training records, policies/procedures, contracts, presentations, plans, reports, clinical trial documents and company patent documents
• Assist in the development, management and maintenance of the Company’s Quality Management System
• Co-manage the Company data rooms/document sharing platforms: assign and approve user privileges, upload documents as appropriate, and maintain to ensure they are kept up to date
• Keep up to date with regulatory guidance and expectations concerning document management and implement change in accordance with current thinking
• Act as the nominated Company Archivist liaising with external providers, managing records of archived documents and materials and controlling access to archived documents and materials
• Provide Company-wide training related to document management
• Assist in the preparation of templates and, from time to time, review, edit and format Scancell documents and presentations to ensure consistency in quality and Company style
• Work with contractors to provide clinical trial-related documents to electronic Trial Master File managers as appropriate PERSON SPECIFICATION Education and qualifications
• Educated to degree level (preferably in a science subject) or equivalent Technical experience
• Previous experience (minimum of 2 years) in a similar role, preferably within life sciences/clinical research
• Excellent team-working skills with the ability to interact and communicate effectively (both verbal and written) with professionals in a multi-disciplinary team
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook, SharePoint) and EndNote.
• Experienced in document management systems/electronic data rooms
• Confident in the use of technology, and the implementation of new technologies, with sufficient knowledge to drive work with IT specialists
• Ideally a working knowledge of the patent application process Key personal skills and abilities
• Excellent written and verbal communication skills, with the ability to interact effectively with colleagues, managers, contractors and service providers
• Methodical approach with meticulous record keeping and attention to detail with focus on quality
• Able to demonstrate confidentiality and personal integrity in all aspects of work
• Excellent organisational skills with the ability to use own initiative and work with limited supervision
• Excellent team worker with equal ability to work alone
• Proven ability to prioritise, plan ahead and manage a high volume of work to meet deadlines, both prescribed and self-imposed
• Able to cope under pressure and be flexible with changing priorities
If you would like to apply, please email your CV and a covering letter to the Company’s HR consultant Mr. Rod Cook, firstname.lastname@example.org , by our closing date of Friday 18th October 2019. The covering letter should clearly demonstrate how you meet the person specification for the post and should include examples of your skills and experience, which may be gained in employment, education, or during career breaks (such as time out to care for dependents).