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Professional women's network

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About the job

Job summary

Are you a Clinical Operations Manager?

Do you want to be part of a small multifunctional group focused on the development and assessment of pharmaceuticals designed to keep our Armed Forces safe and maximise operational performance.

Can you establish and manage a Clinical Operations Unit to enable effective and compliant sponsorship of clinical trials?

Can you help make a difference to the UK's safety and security by applying your Clinical Operations expertise and knowledge in this critical area?

Are you keen to seek new challenges and work collaboratively with colleagues and partners across the UK to deliver solutions?

The work of the Chemical, Biological and Radiological (CBR) Division is aimed at understanding and mitigating the lethal and incapacitating effects of various physical, chemical and biological insults on the human body.

Suitable pharmaceuticals (small molecule drugs or biologicals) are being developed and/or investigated and taken into clinical studies (generally Phase I) with the primary aim of progressing towards a Marketing Authorisation (MA) from the MHRA.

The research and development outcomes may inform a range of strategic and policy decisions across MOD and wider government.
Dstl holds clinical trial Sponsor responsibilities and maintains a GXP Quality Management System primarily focussed on GCP requirements to support MOD Sponsored clinical trials currently delivered externally through CROs in the UK. In the future clinical trials may also be conducted on the Dstl site.

We are looking for someone who has:

Extensive Clinical Operations Management experience

preferably from a commercial environment although, NHS or University setting will be considered.

Experience in the management of a Clinical Trials Unit, which ideally would include the set up, development or maintenance.

A thorough knowledge of clinical trials legislation (GCP & ICH), governance and ethics specifically relating to the conduct of clinical trials in the UK.

Extensive experience of working with QA and the GCP QMS to ensure an oversight of training, competency, SOPs and records management.

Experience of hosting inspections by the Regulatory Authorities.

A proven track record of working collaboratively within successful teams.

Person specification

You'll need a significant level of experience in Clinical Operations management. And will have a thorough knowledge of clinical trials legislation (including GCP and ICH), governance and ethics specifically relating to the conduct of clinical trials in the UK.

You will establish and lead the Clinical Operations Unit at Dstl and work closely with clinicians, other technical SMEs and project managers to enable the successful delivery of the projects within time and budget.

You'll also work with QA and have oversight of the QMS and contribute to performance reports and assurance updates to senior management and be required to engage at all levels within the organisation and externally with the MOD and other organisations, including regulatory authorities.

We are looking for someone with the following;

Essential Qualifications

Degree in a life sciences area, nursing degree or equivalent

Desirable Qualifications

Higher qualification in related scientific discipline or management

Essential Experience

Demonstrable experience of successful Clinical Operations management

Demonstrable evidence of training, coaching and mentoring clinical operations teams

Demonstrable thorough knowledge of clinical trials legislation (GCP and ICH), governance and ethics specifically relating to the conduct of clinical trials in the UK.

Demonstrable evidence of working with QA to manage oversight of a GCP QMS

Demonstrable experience of working with external customers/suppliers

Good organisation and administrative skills with the ability to recognise and set priorities and the ability to organise and co-ordinate work efficiently

Strong Leadership qualities

Good IT Skills

Desirable Experience

A good understanding of the pharmaceutical development lifecycle

An understanding of GLP and GMP regulations and requirements

Important Information

Our work in defence, security and intelligence requires our employees to be UK Nationals who are able to gain a high level of security clearance to undertake the projects we are involved in to protect us from security threats. For this reason, only UK Nationals will be able to apply for this role. If you are an international or dual-national candidate, and you think you have the skills we need, please consider applying to any of our government, security or defence partners.

This role will require full UK security clearance and you should have resided in the UK for the past 5 years

Clinical Operations Manager

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