Clinical Trials Administrator

Cambridge, UK

Description

Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects (including internally led clinical trials and customer led research studies) to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Clinical Trials Administrator to join our busy PMO.

The CTA is a customer facing role, supporting all study activities from start-up until close-out and ensures that all selected clinical sites receive the adequate support and equipment they need to carry out the study. This will involve occasional national and international travel, sometimes at short notice.

You will need superb organisational skills as you will be supporting several studies simultaneously, dependant on size and complexity, and you will need to keep customer satisfaction at the core of everything you do.

Working in collaboration with the clinical trials team and with a wide range of customers, this role is pivotal to the success of Owlstone.For customer led research studies or for internally led clinical trials, you will be expected to work with a Clinical Trials Coordinator / Project Manager to agree the scope of the support activities for a particular study. You will then be expected to take ownership of these activities at each stage for the duration of the study, including:

  • Study Definition – supporting the CTC / PM in the development of the Study Definition Document (SDD) and other key documents.
  • Study Initiation – preparing equipment and logistics and assisting the CTC / PM with the Site Initiation Visit (SIV), operational training, project meetings, etc.
  • Study Execution – being responsible for all study logistics and administration, including coordinating and shipping products and consumables, handling returned samples, updating records, etc.
  • Data Analysis and Study Close Out – ensuring all records and documents are complete and supporting the CTC / PM with study close out.
  • As well as the responsibilities outlined above, you will be expected to support the process development and improvement within the Clinical Trials Team, by helping to define working practices and ensuring non-compliant processes are escalated. You will also be expected to play an active role in the success of the PMO and you may also be asked to deputise, from time to time, for Clinical Trials Coordinators.

Requirements

The following competences form the core strength of the PMO. As a CTA, you are expected to have an awareness of them and, whilst at this stage you may not be able to evidence application of them, you will be expected to take part in supported development activities in order to grow your capability and to progress within the PMO:

  • Leadership & professionalism - the ability to empower and inspire others to deliver successful projects and to act in a morally, legally and socially appropriate manner.
  • Team management - the ability to select, motivate, develop and manage teams to achieve specified objectives and to resolve differences and conflicts between them.
  • Stakeholder management - the ability to identify and effectively engage with all stakeholders, taking account of their levels of influence and particular interests.
  • Planning - the ability to consolidate and document the fundamental components of a project and then prepare and maintain schedules for project activities and events.
  • Financial management - the ability to develop and agree budgets for projects, and to control forecast and actual costs demonstrating commercial awareness.
  • Quality management – the ability to ensure that the project outputs and processes through which they are delivered are meeting stakeholder requirements.
  • Requirements management – the ability to capture, assess and justify stakeholders’ wants and needs to arrive at an agreed schedule of requirements.
  • Risk & issue management – the ability to identify risks (threats and opportunities) and issues, assess them and plan and implement appropriate responses.
  • Benefits realisation - the ability to manage the integration of the outputs of the project into business-as-usual in order to realise the business benefits.
  • Governance - the ability to establish and maintain structures that define clear roles, responsibilities and accountabilities for governance and delivery of the project.

Essential Requirements

  • Experience – you will have experience in a similar CTA or administrative role
  • Knowledge – you will have an awareness of the regulatory issues surrounding clinical trials and research studies, e.g. ethics, data protections, etc
  • Education – you will be educated to “GCSE” level (or equivalent)
  • Communication – you will have excellent written and verbal communication skills and be comfortable interacting with a wide range of customers.
  • Information Technology – you will be competent using a range of IT systems at an intermediate level, e.g. MS Office, Atlassian JIRA and Confluence, etc. 

Desirable Requirements

  • Further education in a technical or science discipline
  • Knowledge of ICH-GCP
  • Experience of working within an ISO 9001 Quality Management System and/or clinical trials regulated environment

About Owlstone Medical

Owlstone Medical (www.owlstonemedical.com) is on a mission to save 100,000 lives and $1.5 billion in healthcare costs through the development and application of Breath Biopsy®. This involves collecting volatile organic compounds (VOCs) and respiratory droplets from breath, which can provide information about metabolic activity and markers related to health and disease.

Breath sampling has substantial advantages for the early detection of disease and to enable precision medicine approaches to patient care. To realize these advantages, Owlstone Medical offers Research Products and Services for biomarker discovery and is developing tests in applications including cancer, liver disease, asthma, and environmental exposure. Our work includes partnerships with major organizations including AstraZeneca, GlaxoSmithKline, the Cleveland Clinic, and the NHS and our platform is in use at well over 100 clinical and academic sites worldwide.

Our leadership in breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit. You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people’s lives. If you want to experience the buzz of a thriving start-up company set to succeed on a global scale, Owlstone Medical could be the place for you.

We do not accept applications from agencies outside of our preferred supplier list. If you are concerned that your application has not been received by Owlstone Medical, please contact us using careers@owlstone.co.uk.


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