Senior Clinical Trials Manager

Owlstone Medical Ltd is on a mission to save 100,000 lives. To achieve this, we design and coordinate a number of projects to discover biomarkers associated with disease and we are looking for an expert in the delivery of clinical trials to lead and support our internal clinical trials.

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 with our multi-disciplinary teams to lead and manage multiple clinical trials including CTIMPs, from the initial scoping stage through to delivery and study close out and ensuring that all clinical sites deliver and recruit as planned against the required timelines and that any issues that delay recruitment are unblocked quickly

Key tasks & Accountabilities

You will be accountable for managing and driving the full life cycle of the study, including outsourced components, for multiple complex research studies including CTIMPs and will be an integral part of our Programme team helping to influence and develop our strategy for the delivery of clinical trials to support each internal therapeutic area

You will have the skills and drive required to step in and ensure that anything related to the implementation and conduct, that comes up during the course of the clinical study is actioned and addressed appropriately and in a timely manner.

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 a Clinical Trial:

Be accountable for complex studies and/or those with high visibility such as pivotal trials or challenging POC studies

Management and oversight of the conduct of the clinical trial, including responsibility for recruitment and ensuring any elements on the critical path, especially recruitment, are unblocked quickly to avoid delays

Collaboration with Programme managers on timelines and delivery

Contribution to the required risk management documentation, ownership for completion of identified risk reduction actions, provide guidance and support for more junior staff and ensure learnings are disseminated accordingly

Management of internal stakeholders, communication and troubleshooting to ensure any issues blocking the delivery of the trial are resolved in a timely manner

Study Set Up

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

Development of the site monitoring plan to ensure compliance with the protocol as required and training the Clinical Monitor

The quality management documentation for individual clinical trials

Lead in-depth site feasibility assessments, ensuring that the selected sites are suitable for the study requirements

Review and where necessary negotiate contracts to ensure all clinical activities are accounted and costed for appropriately

Seek feedback from regulatory bodies and oversee submissions and approvals process, to ensure on time initiation of trials involving medical devices or CTIMPs

Study Conduct

Visit clinical sites and support them in recruitment of subjects, entering data into the CRF, collection of breath samples and any other study related tasks as required and for the purpose of training, monitoring and understand barriers to recruitment

Monitor and critically review the performance of different sites and feedback on this to the appropriate stakeholders and document any deviations to protocol or delivery timelines and work to unblock any issues that will impact on delivery

Ensure the clinical trial, remains compliant to the quality management plan and that the data produced is handled appropriately and that the clinical data meets submission requirements

Present updates and findings to both internal and external customers and collaborators, be able to influence both on the benefits of the trials being conducted and on participation

Study Close Out

Responsible for ensuring the study and TMF are closed out appropriately

Responsible for production of the Clinical Study Report

Training / and other study support

Act as a coach or mentor to junior members of Clinical Study Delivery

Responsible for QC check and peer review of all documentation for delivery to external sites and customers

Quality Management

Ensure that all decisions are documented and that all records and documentation are accurate and stored appropriately according to the appropriate SOPs and provide stakeholder reports as required

Ensuring that non-conformances are logged, lead CAPA investigations and implementation of improvements

Take accountability for the preparation and review of existing and new departmental SOPs, templates and forms

Requirements

Essential

You will have demonstrable experience in a similar role leading / setting up clinical trials and working to GCP guidelines.

You will have experience of management of external clinical sites in the conduct of a clinical trial

You will also have experience of interacting with the MHRA (and/or other regulatory bodies), of reporting serious adverse events and working with different institutional review boards (IRBs) or ethics committees (ECs).

You will also have experience of supporting a range of clinical trials including CTIMPs, from "first in human" studies to Phase 3 clinical trials.

You will have an 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

You will be educated to degree level (or equivalent), ideally in a science subject

You will have excellent written and verbal communication skills and be comfortable supervising others and delivering effective presentations. You will have experience acting as a mentor or coach to more junior team members.

Desirable

You will have demonstrable experience in a similar senior role leading / setting up clinical trials and working to GCP guidelines.

You will have experience of working within a CRO or overseeing work outsourced to a CRO.

Experience of line management, team leadership, coaching or mentoring

Experience of working within an ISO 9001 Quality Management System

Experience of managing clinical trials performed in NHS sites and with clinical trials supporting medical devices approval