Owlstone Medical: Clinical Data Manager

At Owlstone Medical we are aiming to develop a breathalyzer for disease. To support our continuously growing clinical research portfolio we are looking for passionate , innovative individuals to help develop, lead and shape the way we work.

We are currently seeking to hire an experienced data manager for our clinical trials.

Your proven data management expertise will be a key in supporting studies and projects, decision making and driving best practice from a Data Management perspective.

Main duties and responsibilities

  • Provide clinical data management support to internal study teams (including set-up of eCRFs, query management, …)
  • Communicate frequently and provide the right level of support to the internal study team as well as with sites if needed.
  • Actively participate in study team meetings and maintain awareness of the current status of the ongoing studies from a Data Management perspective
  • Responsible for providing guidance on existing/new data standards in Data Management to ensure regulatory compliance
  • Review of key clinical research documents
  • Provide support, guidance and expertise to Data management activities
  • Responsible for the data quality, risk mitigation and assessing solutions within studies
  • Contribute to process development and improvement reviews, help define working practices and ensure non-compliant processes are escalated

Essential requirements

  • BSc or post graduate qualification (or local equivalent) in computing, Life Sciences or equivalent experience
  • Experience as a lead data manager
  • Good knowledge of clinical database applications such as EDC
  • Excellent communication skills
  • Working knowledge of good clinical practice, Clinical research, Clinical trial processes and the related regulatory requirements and terminology
  • Solid knowledge of applicable standards in clinical trial data (CDICS)
  • Ability to demonstrate strong time management and team working skills
  • High attention to detail and an analytical mind-set
  • Flexibility to grow together with the organisation

Desirable requirements

  • Experience on Clinical Device Development trials
  • SAS programing/mapping of data to SDTM
  • CDISC education
  • Technical knowledge of EDC systems

About Owlstone:

Owlstone Medical has developed a breathalyzer for disease.

Every time you breathe out there are hundreds of chemicals on your breath – some are telltale markers of disease that our microchip chemical sensor technology is able to detect.

Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease.

They key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% – unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises 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 Defence.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.

To apply, please submit your CV and a covering letter explaining why you want to work with us and how you fit the role to email.