Clinical Data Manager

The Clinical Data Manager will be responsible for data deliverables for assigned clinical studies and may specialize in Clinical Data Management processes, standards, and technology. They will ensure business continuity for processes and standards including maintaining the integrity of the clinical database for relevant studies. Key Tasks: - Oversee the data management of clinical trials across a complex program. - Lead the development and review of data management processes (such as 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. - Responsible for real-time data management and overall quality and completeness of data. - Report on study status (e.g., providing data to clinical teams for 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 (including data cleaning plan) and provide input into Statistical Analysis Plans where appropriate. - Understand therapeutic area indication or program-specific data capture standard, drive adherence to standards and processes for data quality and consistency, maintain an awareness of the external and internal models to recommend continuous improvement. - Provide input into activities associated with regulatory inspections/audits and 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 developed eCRFs to enable them to train sites and monitors, providing cross-company visibility of study performance metrics. Requirements: - Software programming skills as required. - 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 a proven track record in the Biotech/Pharma/CRO industry. - Demonstrated current understanding of Good Clinical Data Management Practices and relevant guidelines and regulatory requirements. - Experience with Clinical Databases, various 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 concurrent projects and proactively manage time to achieve personal 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. About Owlstone Medical: Owlstone Medical is dedicated to saving 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 significant 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 like AstraZeneca, GlaxoSmithKline, Cleveland Clinic, and the NHS and our platform is in use at over 100 clinical and academic sites worldwide. Our leadership in breath analysis is underpinned by our diverse team, including systems engineers, clinical scientists, analytical chemists, AI specialists, and clinical trials coordinators. The Owlstone group also commercializes various highly innovative products based on its proprietary FAIMS chemical sensing technology in 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 seek the thrill of a thriving start-up 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 your application has not been received by Owlstone Medical, please contact us. Owlstone is an equal opportunity employer. We will consider all qualified applicants for employment without discrimination on any characteristic protected by law including, but not limited to, 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. 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 obtained against all applicable project security and US export control authorizations. Failure to meet any reference, BPSS, project security, or export control authorizations may impact the successful completion of your probationary period. Notice to agencies: Owlstone Medical Ltd requests no contact from recruitment agencies or media sales. We do not accept speculative CVs from recruitment agencies nor accept the fees associated with them.