Clinical Study Manager – Maternity Cover (FTC)

PsiOxus Therapeutics Ltd is an Oxford based biotechnology company developing novel therapeutics with a particular focus upon cancer.  The company has a diverse portfolio and currently has products in Phase I/II clinical development and an innovative pipeline of research stage and clinical trials candidates.

Due to maternity leave we have an exciting opportunity for an experienced Clinical Study Manager to join our busy team on a temporary fixed term contract.  Reporting directly to the Head of Clinical Operations the Clinical Study Manager will support the execution of the clinical strategic plan, within the overall development and business context by managing the clinical operation aspects of clinical trials.  They will work closely with the Chief Medical Officer, the Head of Clinical Operations, and PsiOxus Project Leaders to ensure clinical activities are on target and that project milestone delivery remains on target with regard to time, cost and quality.

This is a full time office-based position located at our facility in Abingdon and will be to cover a period of maternity leave (min 6 months).

Key areas of responsibility will include, but not be limited to:

  • Overseeing the management of the PsiOxus clinical trials by Contract Research Organisations (CROs) and all vendors; proactive issue escalation, management and resolution;
  • Coordinating the monitoring of clinical trials;
  • Performing co-monitoring visits and plan/manage clinical audits;
  • Oversee data review and support medical monitoring for internal data review;
  • Develop and control recruitment strategies,
  • Coordinate drug supplies and shipment of other trial related material;
  • Ensure clinical study files and documentation are adequately maintained;
  • Oversee Case Report Form production by CROs, monitoring and data management plans (contracted to a CRO), and supervise Ethics committee submissions;
  • Support the preparation of protocols, amendments and other related documents as required;
  • Ensure that all aspects of GCP and internal quality systems are adhered to both internally and by the CROs and other vendors;
  • Ensure training of CROs and vendors on the project and associated protocols;
  • Be an active contributor to the clinical and project teams as needed to ensure adequate control of clinical activities, support to the Chief Medical Officer, Head of Clinical Operations and Project Leaders.

We are looking for an enthusiastic, highly motivated and experienced project manager.  Applicants must have at least 5 years’ project management experience and previous CRA/monitoring experience.  A full understanding of all stages of clinical studies and effective risk management skills are essential.  Ideally, the successful candidate will also have oncology and early phase experience.

Applicants must have a clear, demonstrable team-oriented approach to their work and also have the ability to work independently as and when required.  Excellent communication skills, both oral and written are essential together with the ability to liaise effectively with colleagues, external CROs and vendors.  Some international travel may be required.

In return we offer an attractive remuneration package including salary, pension, private healthcare and other benefits.  To apply please click on the Apply button to upload your CV and covering letter.

The closing date for applications is Friday 8 February, however applications will be evaluated in the order that they are received. You are therefore encouraged to apply as soon as possible.