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Clinical Operations Manager


Location: Wiltshire

Job Type: Full time


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.
  • 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 as a gatekeeper to coordinate and oversee all Dstl sponsored clinical trials on behalf of UK MOD.
  • Ensure Dstl Sponsor responsibilities are discharged appropriately by leading the clinical operations activities.
  • Provide strong leadership, knowledge and understanding in this specialist area.
  • Work closely with project managers, clinicians, QA and regulatory functions to ensure appropriate oversight of CRO 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 eg IB, IMPD, CTA.
  • Provide expert review of a wide range of GCP and clinical documentation (e.g. SOPs, TMFs, clinical trial protocols and reports).
  • Contribute to the development of statement of requirements and tender assessments for subcontracted GCP 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 subcontractors 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 Operations activities.

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


We'll assess you against these behaviours during the selection process:

  • Delivering at Pace
  • Communicating and Influencing
  • Leadership
  • Developing Self and Others

Technical skills

We'll assess you against these technical skills during the selection process:

  • Please tell us how you would


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.


Dstl’s full range of great benefits can be found in the information pack which includes:

  • Financial: An excellent pension scheme starting from 26% employer contribution (find out more here). In Year Rewarding Achievement bonuses and thank you vouchers. Rental deposit scheme and cycle to work scheme.

  • Flexible working: Options include alternative working patterns such as; compressed hours (e.g. working a 4 day week/ 9 day fortnight), job shares and annualised hours (agreed number of hours per annum paid monthly i.e. working term-time only).

  • Working hours: Flexibility around your working day (e.g. start time, finish time). Ability to bank hours in a 12 month reference period including the ability to accrue and use 3 days per calendar month.

  • Where you work: Depending on your role, blended working may be available including remote working to suit you and your team. This can be discussed at interview.

  • Annual leave: 25 days pro rata (rising to 30 after 5 years) plus 8 public holidays with the ability to buy/sell 5 additional days per annum.

  • Family: Maternity, adoption or shared parental leave of up to 26 weeks with full pay, an additional 13 weeks statutory pay and a further 13 weeks unpaid

  • Learning and Development: Dstl encourages and supports charterships, accreditations and provides employees access to fully funded apprenticeships up to level 7 (Masters Degree). Dstl will pay for 2 memberships with relevant bodies/institutions. Employees also have access to Civil Service Learning.

  • Facilities: Onsite parking, EV Charging points, restaurants, cafés and gyms.

Things you need to know

Selection process details

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

The sift will be completed the week after the closing date of the 29th October 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 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 20th/21st or 22nd November.

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 and we will do all we can to support you

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


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.