Clinical Trials Administrator
Owlstone Medical’s mission is to save 100,000 lives and save health care providers $1.5B. With several major projects underway to develop disease screening and diagnosis based on detection of metabolic products in breath.
As a Clinical Trials Administrator (CTA) you provide the required level of support to all members of the clinical trials team and across a multiple set of clinical trials.
The role is a key function to ensure all clinical trials run efficiently, ensuring that the required documentation is in place, logistical support is provided, giving administrative support (tracking, data review, …).
- Support the Clinical Team with logistical and administrative tasks related to trial start-up, study conduct and closing of clinical trials to ensure optimal management of the clinical trials.
- Participate in study team meetings as needed and provide accurate meeting minutes and ensure action points are tracked and followed up
- Ensure that the Trial Master Files of different studies are kept up to date
- Review of regulatory and clinical research documents as needed
- Provide support to clinical monitors and sites to ensure that accurate and complete regulatory documents are in place on site (this includes distributing, collecting, reviewing, tracking and archiving documents, agreements and training documentation)
- Support studies for all logistical aspects (supply delivery, preparation of technical monitoring visits, sample tracking, …) and follow up with the clinical trials team and/or site as needed
- Assist in eCRF data review and query tracking
- May be requested to assist in monitoring the data quality, risk mitigation and assessing solutions within studies
- Report, track and follow up on reported customer and site feedback (hardware and software issues, potential safety issues,….)
- Contribute to process development and improvement in the Clinical Team, help define working practices and ensure non-compliant processes are escalated
- Communicate frequently and provide the right level of support to the wider
- As and when needed, assist in breath sample collection for internal, experimental studies
Competencies & Requirement of the Role:
- Computer literate (Word, Excel, Powerpoint, …)
- Excellent organisational and clear communication skills
- Accurate and detail-orientated
- Ability to work in a team as well as independently
- Eager to learn
- Flexibility to grow together with the organisation
- Hands-on attitude, flexibility to take up variety of tasks
- Open to do administrative work such as maintaining trackers, recording meeting minutes, …
- Knowledge of ICH-GCP and Good Documentation Practices
- Person Specification:
- Education & Training:
- No specific training or degree is required for the role
- Experience as Clinical Trial Administrator or equivalent experience in Clinical Research is preferred
- Through knowledge of Word – Excel – Powerpoint
- Organisational and communication skills
Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.
Every time you breathe out there are hundreds of chemicals on your breath - some are tell-tale 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. The 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.
Owlstone is an equal opportunity employer and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.
Due to the nature of our business, all employment is subject to satisfactory references being obtained and attainment of a Baseline Personnel Security Standard (BPSS) check.
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 by clicking on the link below.