The MPS trial team currently manages two novel stem cell gene therapies for children with mucopolysaccharidosis type IIIA (MPSIIIA Sanfilippo) and type II (MPSII; Hunter).
We seek an enthusiastic project manager to contribute to the smooth running of our gene therapy clinical trial programmes, alongside other members of the MPS gene therapy trial team. The Research Project Manager will be a member of the Division of Cell Matrix Biology & Regenerative Medicine, working with the MPS gene therapy trial team. This post will be under the line management of the senior MPS Trial Project Manager, who will provide day-to-day project manager support and acts as the operational lead.
Experience in multidisciplinary working is essential, as the post holder will work between the University of Manchester trial Sponsors office, the clinical site, the CRO responsible for trial monitoring and various contracted third parties, to ensure operational co-ordination and all patient visits are conducted to protocol. You will have specific responsibility for developing and managing systems for the assurance of compliance with the requirements of the Medicines and Healthcare products Regulatory Agency (MHRA) in relation to CTIMPs (Clinical Trial of Investigational Medicinal Product) and ATIMPs (Advanced Therapy Investigational Medicinal Product) and provide project administration through all stages of the research life cycle.
You will be responsible for ensuring deliverables and milestones are met on time and within budget, working with internal and external research administration and finance teams. You will need to work effectively across complex research organisations, be able to take initiative where necessary and identify and breakdown tasks as required to achieve objectives. You will have excellent interpersonal, communication, IT, and organisational skills, will be able to work with minimal supervision, and will have experience within research, preferably in medical sciences. Adherence to good clinical practice (GCP) is essential to this role, particularly with regard to data handling and record keeping.
The post holder will also support the development and submission of new research grant and industrial funding bids and support the processing of clinical trial samples.
As an equal opportunities employer we welcome applicants from all sections of the community regardless of age, sex, gender (or gender identity), ethnicity, disability, sexual orientation and transgender status. All appointments are made on merit.
Our University is positive about flexible working you can find out more here
Blended working arrangements may be considered
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