Senior Study Manager

To fulfil our mission to save lives, we conduct a range of clinical studies, including observational trials, first in human trials, proof of concept studies and later stage trials as required in order to support breath biomarker discovery, development and safety assessment of novel probes of metabolism and medical device development and approval. This diversity means that every study has its own unique challenges to overcome.
In this role, you will work within our Clinical Trials team taking the lead on one or more clinical trials, from the initial scoping stage through to delivery and study close out, ensuring adherence to regulatory and ICH GCP requirements.
Key Tasks & Accountabilities
Reporting into the Head of Clinical Trials, you will be accountable for managing and driving the full life cycle of one or more studies across our programme.
You will be responsible for the following, in addition to any additional tasks outside the scope of this job description as necessary to ensure successful delivery of Clinical Trials:
Study Set Up

• Significant input in the development of study design, protocol, and strategy for delivery of designated trials and preparation of the appropriate documentation


• Lead in-depth site feasibility assessments, ensuring that the selected sites are suitable for the study requirements and recruitment targets.


• Lead on site initiation activities to ensure the timely initiation of clinical trials at sites delegating to junior team members where required.


• Responsible for the identification and development of the study specific processes and plans (e.g. risk management, monitoring plan, PD review) to ensure compliance with the protocol, ICH GCP, regulatory requirements and Owlstone SOPs as required.


• Lead or contribute to the selection of study specific vendors including CROs


• Review and negotiate contracts and budgets to ensure all study related activities are accounted for and costed appropriately.


• Assign study specific roles and responsibilities ensuring all aspects of the study are managed and that relevant parties are aware of their responsibilities.


• Responsible for the preparation, review, and submission of packages to EC/IRB and regulatory bodies ensuring correct documentation and approvals are in place.


• Delegate study specific tasks to the appropriately trained study team members.


• Organise and lead both internal and external study specific kick off meetings


• Review and approve regulatory green light forms ensuring that all requirements are met to activate study sites.


• Work closely with internal stakeholders and Data Manager to ensure that study specific database is created and delivered according to timelines and ensuring that the correct study data is captured to meet study objectives.


• Report/update progress to Head of Clinical trials escalating/highlighting critical path items that require mitigation.


Study Conduct

• Lead the management of study vendors including CROs.


• Monitor and critically review study recruitment and metrics and feedback to the Head of Clinical Trials and appropriate stakeholders ensuring that critical issues that may impact study delivery are resolved.


• Identify, plan, and implement mitigation strategies to ensure the successful delivery of key milestones.


• Lead on data cleaning planning ensuring that complete and accurate data is delivered according to study timelines.


• Prepare and present study specific updates at internal meetings.


• Ensure all study specific reporting is carried out on time and in accordance with regulatory requirements (e.g. DSUR, annual reports)


• Ensure that studies are delivered according to both the study protocol and Owlstone SOPs ensuring overall safety and compliance to ICH GCP standards.


• Identify, plan and lead on amendments throughout the lifecycle of the study ensuring appropriate documents are submitted to the EC/IRB and regulatory bodies.


• Take the lead on CAPA investigations including reporting of serious breaches and implementation of improvements.


Study Close Out

• Responsible for ensuring that all study close out activities are performed according to regulatory requirements.


• Coordinate the production of the Clinical Study Report ensuring that that submission is made according to regulatory requirements and timelines.


Training / and other study support

• Act as a line manager, coach or mentor to junior members of Clinical Trials Team


• Contribute to internal clinical trial specific training including the development and delivery of training materials


• Take the lead in Inspection readiness activities including SOP development
  
  Educated to degree level (or equivalent), ideally in a science subject, Demonstrable experience in a similar role leading global clinical trials including CTIMPS, first in human studies to phase 3 clinical trials and working to GCP guidelines.


• Experience of management of external clinical sites in the conduct of a clinical trials


• Experience of interacting with regulatory authorities (e.g. FDA, MHRA), of reporting serious adverse events and working with different institutional review boards (IRBs) or ethics committees (ECs).


• Extensive knowledge and application of (amongst others) FDA regulations, GCP and ICH Guidelines for clinical research and ethical submissions for clinical trials and the regulatory / ethical requirements with regards to conducting clinical trials for CTIMPs and/or medical devices


• Excellent written and verbal communication skills and be comfortable supervising others and delivering effective presentations.


• Experience of line management or acting as a mentor or coach to junior team members.


Desirable

• Experience of medical device studies
  
  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.
  
  About Owlstone Medical, 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.