Description
The Clinical Data Manager will support and/or be accountable of data deliverables for assigned clinical studies and may be a specialise on Clinical Data Management processes, standards and technology. Maintains business continuity for processes and standards including integrity of the clinical database for the relevant studies.
Key Tasks:
- Oversee the data management of clinical trials across a complex programme.
- Lead the development and review of data management processes (e.g. process and standards, innovation, training)
- Lead the design and validation of the CRF specifications and edit checks for the electronic data capture system for each study.
- Drive data strategy – assessment of risks and mitigations related to data management in collaboration with different stakeholders on a study level.
- Accountable for real time data management and overall quality and completeness of data
- Study status reporting (e.g., provide data to clinical teams for performing medical and clinical reviews, coordination of data review, lab data review etc), oversight of the data and document quality.
- Develop study specific monitoring and Data Management Plans (incl. data cleaning plan) and provide input into Statistical Analysis Plans where appropriate.
- Understands therapeutic area indication or programme specific data capture standard, drives adherence to standards and processes for data quality and consistency, maintain an awareness of the external and internal models in order to flag for continuous improvement.
- Provide input into activities associated with regulatory inspections/audits and to the selection and use of software systems, devices and vendors
- Responsible for building and maintaining Owlstone’s eCRF infrastructure (Open Clinica) to specification.
- Provide training and support for Owlstone Medical personnel on the use and applications of the developed eCRFs so as to enable them to train e.g. sites and monitors,. II. Enabling cross-company visibility of study performance metrics
Requirements
- Software programming skills as required to fulfil job requirements.
- Understanding of database structures, programming languages, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting
- Knowledge of clinical data management and proven track record in Biotech/Pharma/CRO industry
- Shown current understanding of Good Clinical Data Management Practices and relevant guidelines and regulatory requirements.
- Experience of Clinical Databases, different systems, and electronic data capture systems (EDC preferred system openclinica) – understanding and experience in query management process and reconciliation activities
- Ability to work flexibly in a distributed team environment on simultaneous projects and proactively manage time to meet own goals.
- Excellent written and verbal communication skills, interpersonal and analytical skills and high attention to detail
- Ability to work independently and as part of a team
Benefits
About Owlstone Medical
Owlstone Medical 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
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 the attainment of a Baseline Personnel Security Standard (BPSS) check. Access to selected project information requires prior additional security authorization. Access to US technical data by employees requires prior Export Control function approval. Full clearance must be satisfactorily attained against all applicable project security and US export control authorisations. Failure to meet any reference, BPSS, project-security or export-control authorisations may have an impact on successfully completing your probationary period.
Notice to agencies
Owlstone Medical Ltd politely requests no contact from recruitment agencies or media sales. We don’t accept speculative CVs from recruitment agencies nor accept the fees associated with them.