Permanent Position: Full Time. Part-Time and Flexible working considered
Flexible location: Can be homebased. Willingness to travel to Sheffield and study sites as required
Compensation: Industry competitive compensation (payroll +Pension +Bonus)

Why Rinri Therapeutics?
Rinri Therapeutics is a cutting-edge biotechnology company based in Sheffield (UK) dedicated to developing a completely new cell therapy paradigm to treat hearing loss. Our science originates
from the world-renowned Stem Cell Institute at the University of Sheffield and the world-leading research from Professor Marcelo Rivolta on pluripotent and progenitor cells (see Chen et al., 2012 doi: 10.1038/nature11415). Since our inception in late-2018, we have established a world-class team to realise the vision of meeting unmet patient and clinical needs in hearing loss and improving patients’ quality of life on a global scale.

What do we want?
Rinri has a small, ambitious, and multi-skilled entrepreneurial team with extensive scientific, clinical, operational and commercial experience. The Clinical Operations Manager will sit within the Clinical Development and Operations Team who are currently working on the set up of the first in human trial of our lead product, the world’s first regenerative cell therapy for hearing loss. This person will use their in-depth knowledge of clinical research operations to collaboratively deliver the projects from early study start-up to close-out. This person with work closely with clinical development scientists and will provide day to day support to a clinical operations coordinator and clinical operations associate. This role will report to and be supported by the VP for Clinical Development.

We are offering the opportunity for someone with experience in clinical operations project management to become part of the clinical development of a first in class ATMP, working within a truly pioneering UK biotechnology company looking to realise the long-promised potential of cell therapy to improve patients’ lives.

Responsibilities (to include but not limited to):

  • Oversight of clinical trial conduct, including study start-up, enrolment, study conduct, monitoring and close-out.
  • Developing metrics to monitor study progress and to ensure compliance with and adherence to the protocol and relevant SOPs
  • Significantly contribute to the development and implementation of SOPs and processes
  • Collaborative development of essential documents, study plans and training materials
  • Coordinate preparations for Research Ethics Committee and Regulatory Authority approval, including completion of application through IRAS and compiling of all supporting documents. Similarly, managing amendments and ensuring accurate version control
  • Development and implementation of a trial monitoring plan to ensure high quality trial conduct, using a mixture of central monitoring and site visits, appropriate to the trial
  • Implementation of IMP and N-IMP sourcing and logistics
  • Responsibility for the development, set up and maintenance of Trial Master Files / Site Files
  • Project management of the trials/studies, working closely with stakeholders to ensure milestones are met and the trial is delivered on time and within budget
  • Management of recruiting sites and vendors (e.g.CROs, labs) to ensure performance expectations are met
  • Proactive identification of potential study issues and risks. Recommend corrective and preventative actions and follow-up through to resolution
  • Collaborate in the development of the Case Report Forms, and oversee the CRO in the design and testing of the trial database(s). Proactively identify any needed changes to the CRF/EDC over the course of the trial.
  • Performing site visits to facilitate study set up and initiation, regular monitoring visits during patient recruitment, and close out visits on study completion, or oversight of staff undertaking these visits, including sign off of monitoring reports.
  • Working with the CRO and site staff to ensure timely and accurate data collection, monitoring data quality and completeness.
  • Ensuring that all study adverse events are appropriately investigated by the study staff and accurately reported to the investigators and regulatory bodies as required.
  • Coordinating internal meetings, investigator meetings, oversight committees and other trialspecific meetings by organising and minuting meetings, and following up on agreed actions
  • Provision of regular and ad-hoc information, both written and verbal, to sites, oversight committees, regulators, and participants, as required. To include reports, updates, guidance, and newsletters, as appropriate
  • Any other duties as assigned

Required Experience and Skills:

Essential:

  • University degree and significant experience in clinical research, with a track record of successful set-up and completed trials as a Clinical Trial Manager and/or Project Manager
  • Comfortable in a dynamic small company environment and able to adjust workload and responsibilities based on changing priorities
  • Demonstrable understanding of statutory Clinical Trial regulations, governance and ICH-GCP
  • Experience of developing trial-related documentation (essential documents and plans) and preparing complex reports
  • Previous experience delivering a trial with NHS secondary care sites
  • Experience of conducting on-site training
  • Working understanding of the cross-functional requirements for trial set-up and delivery
  • Good analytical and organisational skills, attention to detail and lateral thinking
  • Excellent interpersonal, verbal and written communication including confidence with scientific writing and progress report authoring
  • Line management and/or mentorship

Desirable:

  • Experience with submitting applications and/or amendments through IRAS
  • Experience of close working with clinical development colleagues
  • Clinical Trials experience in translational / early phase / first-in-human clinical trials
  • Experience with an ATMP, including an understanding of cell therapy logistics
  • Experience in audiology/otology
  • Experience of site monitoring, vendor audits and regulatory body inspections

Application Process:

Deadline: Application will be considered on a rolling basis, and no further applications will be accepted after 3rd January 2024.

Application Requirements: Please send a CV and detailed cover letter specifically addressing why you would be a good addition to the Clinical Operations Team at Rinri to: rachel.haines@rinri-therapeutics.com

Contact: Questions may be addressed to the Vice President of Clinical Development, Rachel Haines, on the above email address

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