Senior Clinical Project Manager
- Location: Central London
- Salary: £60,000
- Clinical Project Management Experience Including EU Trials ESSENTIAL
- Experience of Working With Novel Therapeutics ADVANTAGEOUS
- Experience of Working With or In NHS Clinical Trial Structure ADVANTAGEOUS
This is an exciting opportunity for a Senior Clinical Project Manager to join a leading Regenerative Medicine research organisation based in Central London. The company aims to support the commercialisation and development of Cellular Therapies in the UK by providing a range of services to do so. The company collaborates with academic and industrial partners offering manufacturing, technical, development, quality, regulatory services plus taking / sponsoring products through clinical trials. Due to an increase in the volume of clinical trials they need to recruit a Senior Clinical Project manager to join their team.
The company’s aim is to support the UK Cell Therapy industry to become global leaders in the field of regenerative medicines. This is a relatively new area of research that is rapidly developing because the potential this has for the treatment of serious diseases. The advantages of using Cell Therapies for the treatment of diseases is they will focus on the root cause rather than the symptoms like many traditional treatments. Cell therapy uses cells from the affected patient, or already acquired stem cells, or suitable donors to create personalised regenerative medicines treating a wide range of therapeutic areas. The company aims to bridge the gap between late stage clinical development and early stage research. They are working in close association with the NHS and the government providing technical, clinical, manufacturing, and regulatory expertise to help develop a UK Cell Therapy Industry. They recently received significant investment to construct a cell and gene therapy manufacturing facility. To produce products for use in Phase III clinical trials to increase the UK’s manufacturing capabilities. Something that is unique to the UK.
The role of a Senior Clinical Project Manager is to plan, implement and monitor the progress of clinical trials sponsored by the company or on behalf of collaborative partners. With the responsibility for the day to day operational management of the trials. You will ensure the trials are delivered on time and to the right regulatory standards, which includes the management of 3rd parties.
The trials are predominantly conducted in the UK with some based in the EU, over time this will increase along with the volume of trials. You will be involved in the projects from inception to close out, setting out the protocols, CRF and other relevant documents for the trials. Ensuring these comply with regulations and delivered on time taking action where necessary to implement any corrective actions. The responsibilities also include project budgets, the negotiations with 3rd parties, and oversight of clinical vendors.
The company are closely linked to the NHS so you will be required to network and navigate through the NHS structure for trial approval, and contract negotiations. The need for travel is up to 20% within the UK and the potential need for EU travel.
You will need to have prior demonstrable experience of working in a similar role previously with sound knowledge of the NHS clinical trial structure. Ideally you will have experience of managing trials within the EU combined with a clinical research background, including clinical monitoring with medical and / or scientific experience. In depth Knowledge of GCP and other regulations is essential. Knowledge of the NHS regulatory and operational methods is advantageous to your application as well as familiarity of working with novel therapies including cell therapies.
Project Manager, clinical trials, monitoring, GCP, cell therapy, novel therapy, gene therapy, NHS, budget, CRF, EU, protocol, SOP, clinical project manager, 3rd party, vendor, TMF, CRA, CRO, budget, manage,
This is a permanent role
To apply for this role, please contact James Hume on 01403 216216 or email your CV to: email@example.com
Opening For Senior Clinical Project Manager : London
Senior Clinical Project Manager