Description
A Global Medical Device company are looking for a Clinical Project Manager on an initial 6 months contract. They are based in Cambrideshire and would allow some flexibility with home workingThey are specifically looking for someone with Medical Device experience with the emphasis on clinical trials. You will have needed to have run CE trials and previous experience getting a product FDA approved would be beneficial. The product itself is a class III device and therefore invasive device experience would also be beneficial.
Some of the key responsibilities include:
Site monitoring responsibilities for clinical studies according to SOPs, ICH Guidelines and GCP.
Attend and Participate in investigator meetings.
Manage study budgets and contracts including negotiations.
Look after more junior CRAs.
Identify new investigators for future studies.
Review CRF's and provide relevant feedback
Assist with IRB/IEC submissions as required.
Attend study team meetings.
Required skills and experience:
CE trials experience.
Monitoring experience.
Experience in the use of project management tools .
Previous working experience of the European or US regulations/standards affecting clinical studies for Medical Devices or IVDs.
If you are interested in this role please respond ASAP with an updated CV and your location and availability to start and to interview.
Please pass this on to friends or colleagues as we offer referral vouchers.
Thanks and regards,