Clinical Trials Specialist

Job content

PsiOxus Therapeutics Ltd is an award-winning UK/US development stage biotechnology company developing novel “tumour re-engineering” therapeutics for the treatment of cancer, with a focus on immunotherapeutic approaches. We currently have two transgene-expressing T-SIGn cancer gene therapy candidates in Phase I/II clinical development and are further developing our innovative platform technology and pipeline of new pre-clinical and research candidates.

We have an exciting new opportunity for an experienced Clinical Trials Specialist to assist with clinical activities to support the PsiOxus portfolio of research and development projects. All activities need to be carried out with regards to time, cost, and quality and in accordance with SOPs, ICH/ GCP guidelines and local regulations.

The Clinical Trials Specialist will be expected to work across ongoing PsiOxus clinical trials; they will work closely with the VP, Clinical Operations, and the Clinical Operations team (Clinical Study Managers, Clinical Site Liaison Manager and the Clinical Operations Administrator)

The responsibilities of the role include, but are not limited to, the following key activities:

· Support Clinical Study Managers to ensure studies are set up and managed according to PsiOxus SOPs and within agreed timelines

· Support preparation of IB, protocols and amendments, patient facing documentation, DSUR and other internal documents in time for key study milestones

· Assist in development and review of clinical study plans and manuals

· Assist with the tracking of PsiOxus review of CRO monitoring visit reports and review visit reports as agreed with the Clinical Study Manager

· Assist with the ongoing maintenance of the Sponsor Oversight File, tracking and essential document management

· Ensure clinical study files and documentation are adequately maintained; regular review of the CRO TMF

· Review draft minutes and presentation slides from meetings with CROs, sites and external vendors, as required

· Assist with the tracking of clinical samples and liaising with sites (as required) regarding clinical sample status

· Support the distribution of Clinical Supplies to clinical sites

· Attendance at clinical and project team meetings as required

· Ensure that all aspects of ICH GCP and internal quality systems are adhered to internally and by third parties

Other key activities that are required to support the PsiOxus portfolio of research and development

We are looking for an enthusiastic and highly motivated self-starter with a minimum of 2 years’ experience of clinical trials in a CRO or Biotech environment. You should also have previous experience in reviewing plans and documents as well as maintaining study files.

You should be comfortable working to tight deadlines and capable of readily adapting to changing priorities in a fast-paced, team-focused scientific environment. The ability to innovate is essential, as is a proven ability to work and communicate effectively as part of a team and have good knowledge of GCP practices.

This is a fantastic opportunity to join our team at an exciting time and become part of something very special. If you would like to apply please ensure you upload a covering letter as well as your CV, explaining to us why you are interested in this position. In return we offer a great working environment, an attractive remuneration package and a range of competitive benefits.

Part-time hours: 25 - 28 per week

Job Types: Full-time, Part-time, Permanent

Salary: Up to £55,000.00 per year

Additional pay:

• Performance bonus

Benefits:

• Additional leave
• Bike to work scheme
• Company events
• Company pension
• Life insurance
• On-site parking
• Private medical insurance
• Store discounts

Schedule:

• Monday to Friday

COVID-19 considerations:
All employees have to wear masks when moving around the business. Desks and touch points are sanitised regularly. All visitors to site must complete a pre-covid questionnaire.

Education:

• Bachelor’s (preferred)

Experience:

• clinical project management: 1 year (preferred)

Work remotely:

• Temporarily due to COVID-19