At Shionogi we have exciting plans with the launch three new products, including a new action anti-biotic, Cefiderocol. We have a strong pipeline of clinical projects. As a Study Manager you will have a broad remit and be involved in the launch of our next generation of products. In this role you will have a high level of responsibility and exposure to all aspects of clinical operations.

You will plan and manage the overall clinical operations for assigned clinical trial(s) including timelines, budgets, resources, vendors and key project deliverables. Working in a matrix environment you will provide management to functional area representatives, as well as supporting the clinical sub-teams. Due to size of our operations, this is an opportunity to be hands on and have key strategic input. You will have the opportunity to work with colleagues global, meet with investigator and visit study sites.

We are growing organisation in Europe, with the support of our parent company Shionogi & Co Japan. Being research led we always put our patients first. We have an enviable record of discovering important medicines including Crestor(Rosuvastatin), Avalon (Moxifloxacin), Cymbalta (Duloxetine) and Dulotegravir (HIV-integraseinhibitor).

For this role your main duties will include:

• Providing matrix management of functional area representatives in cross-functional clinical trial teams, including ensuring proper resourcing for assigned trials, leading clinical trial teams and managing accountabilities for all clinical trial team members.
• Developing operational study level feasibility, recruitment strategies and the delivery of the approved Study Protocol
• Developing outsourcing specifications for vendor requests for proposal, leads vendor selection and oversees vendor management throughout the life of assigned clinical trial(s).
• Ensuring sponsor oversight of clinical trials including the selection of investigational sites with input from Clinical Development and vendors and oversight of investigational sites' adherence to pertinent regulations through review of monitoring reports, QA-GCP audit reports and communications with study /site personnel
• Developing and managing study timelines

To become part of our growing team, you will have:

• Successful experience as a Study Manager or Clinical Project Manager
• Progressive experience in clinical operations including site management and monitoring or equivalent and project management experience or equivalent.
• A bachelor’s degree or equivalent in the Sciences, a higher degree is desirable
• PMP and/or other Project Management certification is a bonus

To be success you will be a culturally aware, have flexible approach to working and be able to integrate into a harmonious team

If you have the right experience and skills and are excited by the role, please apply: