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Clinical Study Manager

Clinical Study Manager for a Global Medical technology business based in Hull

Your new company
Global medical technology business based in Hull

Your new role

To manage a programme of clinical studies and related clinical activities. This includes management of specific clinical research projects against agreed programme milestones. The position liaises with a broad range of commercial, regulatory and scientific professionals across the Business.

80% - Delivery of Clinical Research Projects

  •  To manage clinical research projects, as allocated by the Director Clinical Operations, and to form, lead and manage project teams to ensure delivery against the agreed project plan. 
  •  Ensure appropriate clinical research input into projects (Research, Development or Marketing) via a proactive approach to team membership. 
  •  Assist in estimating costs of proposed trials, recording spends during projects, and review against budget. 
  •  Produce the documentation required to plan, carry out and report clinical and volunteer studies. E.g. protocols, ethics submissions, patient information sheets, study reports. 
  •  Co-ordinate appropriate monitoring of the study live phase, supervising Trial Monitors where necessary, and ensuring that non-conformities identified during the trial are dealt with appropriately. In circumstances where external contractors are used to provide Clinical Research Services, the jobholder will assist in managing this interface. 
  •  Provision & delivery of product supply required in clinical and volunteer studies. Production of CSSP’s where necessary. Planning and execution of labelling processes. Distribution, tracking and reconciliation of all product supplies as required by SOP’s and protocols 

10% - Systems and Compliance
  •  Ensure that Clinical and Volunteer Study related activities are carried out in accordance with the appropriate Good Clinical Practice (GCP) guidelines. This will usually be ICH GCP for medicines and ISO 14155 for Medical Devices, within the ISO9001 quality system. 

10% - Technical Project Administration
  •  Utilise eTMF, EDC and other system as required. 
  •  Develop, improve and ensure maintenance of departmental databases/spreadsheets and clinical study status tracking systems. 

What you'll need to succeed

  • At least 3 years experience as a CSM with successful management of multiple studies. Must have device study experience, experience with EDC , monitoring, trial management 
  • EDC and eTMF experience necessary 
  • Medical devices experience 
  • mostly phase 4, some phase 1 experience
  • Wounds (chronic and acute) therapy area experience
  • Mostly UK, some EU.
  • motivated, organised, proactive, ability to project manage, good communication and interpersonal skills

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.


Job Type:
Life Sciences
Hourly Rate
Apply Now

Talk to a Consultant

Talk to Sasha Sehdev, the specialist consultant managing this position, located in London City

107 Cheapside, London, EC2V 6DN

Telephone: 02034650079
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