About the job

Job summary

Are you a Clinical Research Operations Manager? 

Would you like to be part of a small vibrant multifunctional group, comprising pharmaceutical development staff and project managers, focused on the development and assessment of pharmaceuticals designed to keep our Armed Forces safe and maximise operational performance?

Can you make a difference to the UK's safety and security by applying your Clinical Operations, clinical research 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. Pharmaceuticals are being developed and/or investigated and taken along the drug development pathway, including clinical trials with the aim of Marketing Authorisation (MA). 

The research and development outcomes may inform a range of strategic and policy decisions across MOD and wider government. 
Dstl acts as Sponsor on behalf of MOD and as such has statutory responsibilities. It therefore maintains a GxP Quality Management System primarily focussed on GCP requirements to support Dstl-sponsored clinical trials. Many of these are currently delivered externally through CROs in the UK, although some may be conducted at the Dstl site.

We are seeking a Clinical Research Operations Manager to join our team to establish and manage a Clinical Operations Unit. This role will provide effective strategic management, oversight and regulatory compliance for the sponsorship of clinical trials across all phases.

We are looking for someone who has:

• Extensive Clinical Research Operations Management experience from commercial or non-commercial backgrounds such as industry, biotech, NHS or University. 
• Experience in the management of Clinical Trials both in the sponsorship role and conducting/managing clinical trials at a site. Ideally this would included set up, development, maintenance and closedown of trials.
• A thorough knowledge of the clinical trials regulatory landscape (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.
• The ability to organise, plan and implement projects to time and cost.
• Strong leadership, written and verbal communication skills.
• The ability to influence at all levels of the organisation.

Job description

In this role you will:

• Act to facilitate, coordinate and oversee all Dstl-sponsored clinical trials on behalf of UK MOD.
• Ensure Dstl Sponsor responsibilities are discharged appropriately by leading the clinical research operations activities.
• Provide strong leadership, knowledge and understanding in this specialist area. 
• Work alongside the Dstl Chief Medical Officer and other clinicians to undertake sponsorship risk assessment of interventional clinical trials.
• Work closely with project managers, clinicians, QA and regulatory functions to ensure appropriate oversight of CRO and site activities.
• Work with QA to ensure appropriate training is in place at all levels of the organisation.
• Ensure the GXP QMS is fit for purpose with oversight of training, competency, SOPs records management etc.
• Ensure all documentation supporting clinical trials is generated in a timely manner, e.g. IB, IMPD, CTA.
• Work as part of the team provide expert review of a wide range of GCP and clinical trials documentation (e.g. SOPs, TMFs, clinical trial protocols and reports).
• Contribute to the development of statements of requirements and tender assessments for subcontracted GxP activities. 
• Work collaboratively across interdisciplinary teams to ensure delivery. 
• Exercise sound judgement to reach evidence-based decisions and be confident and clear in presenting your ideas and work to a variety of technical and non-technical audiences. 
• Manage and conduct interactions with external sub-contractors to ensure positive and trusted relationships are developed.
• Play a lead role with QA in hosting Regulatory Authority (MHRA) inspections.
• Promote and raise the importance of Quality Management issues within the organisation and amongst stakeholders.
• Organise your time and be able to prioritise key activities.
• Play an important role in coaching those individuals involved in clinical research activities.
• Work safely in accordance with Dstl policies and procedures

Person specification

You will have a strong track record in Clinical Research Operations management with experience of both the commercial and non-commercial models. 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 help to establish and lead a Clinical Research Operations Unit at Dstl. Working alongside the Dstl Chief Medical Officer, clinicians, other technical SMEs and project managers this unit will enable the successful sponsorship and delivery of interventional clinical trials, within time and budget, on behalf of UK MOD.

You will work with QA, have oversight of the QMS and contribute to performance reports and assurance updates to senior management.

You will also be required to engage at all levels within the organisation and externally with the wider MOD and other organisations, including regulatory authorities. 

We are looking for someone with the following;

Essential Qualifications

• Undergraduate degree in a life sciences area, nursing degree or equivalent
• Research methods training
• Evidence of Continuing Professional Development
• Recent GCP training
  

Desirable Qualifications

• Higher qualification in related scientific discipline or management 

Essential Experience

• Demonstrable experience of successful Clinical Research 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

Benefits

Alongside your salary of £54,961, Defence Science and Technology Laboratory contributes £16,858 towards you being a member of the Civil Service Defined Benefit Pension scheme. Find out what benefits a Civil Service Pension provides.

Things you need to know

Selection process details

This vacancy is using Success Profiles (opens in a new window), and will assess your Behaviours and Experience.

The sift will be completed the week after the closing date of the 05th January 2024 and will assess how your CV/Personal Statement matches the requirements for the role as detailed in the attached job description.

The Interview will consist of a presentation, combined technical and behavioural interview assessing your skills and experience in relation to the job description. Successful candidates at sift will be invited for an in person interview at Porton Down on the week commencing the 22nd January 2024 .

We want you to have your best chance of success in our recruitment process, so If at any stage of the application process you would like help or assistance please contact the Dstl Recruitment Team dstlrecruitment@dstl.gov.uk and we will do all we can to support you

Feedback will only be provided if you attend an interview or assessment.

Security

Successful candidates must undergo a criminal record check. Successful candidates must meet the security requirements before they can be appointed. The level of security needed is security check (opens in a new window).

See our vetting charter (opens in a new window). People working with government assets must complete baseline personnel security standard (opens in new window) checks.

Nationality requirements

Open to UK nationals only.

This job is not open to candidates who hold a dual nationality.

Working for the Civil Service

The Civil Service Code (opens in a new window) sets out the standards of behaviour expected of civil servants.

We recruit by merit on the basis of fair and open competition, as outlined in the Civil Service Commission's recruitment principles (opens in a new window). The Civil Service embraces diversity and promotes equal opportunities. As such, we run a Disability Confident Scheme (DCS) for candidates with disabilities who meet the minimum selection criteria. The Civil Service also offers a Redeployment Interview Scheme to civil servants who are at risk of redundancy, and who meet the minimum requirements for the advertised vacancy.