Study Start-Up Manager - Medical Devices
- Clinical Research, Clinical Administrator, Clinical Project Manager, Clinical Research Associate, Clinical Research Nurse, Clinical Services, Clinical Supplies, Clinical Trials Manager / Administrator, Drug Safety, Feasibility, Pharmacoeconomics, Pharmacovigilance, Study Site Coordinator, Study Start Up, Data Management / Statistics, Clinical Data Management, Informatics, Statistics, Medical Affairs, Medical Advisor, Quality, QA / QC, Quality Validation Engineer, R & D , Pre - clinical, Regulatory Affairs
- Efficiently manage and successfully execute all aspects of global device trial start-up according to Sponsor specifications;
- Oversee regional and/or global operational team preparing submission packages
- Prepare and/or review documents for RA and EC submission packages
- Review pertinent regulations to develop proactive solutions to start-up issues and challenges
- Provide advice to sponsors and project teams on device regulations and strategies
- Present during bid defenses, general capabilities meetings, and audits.
- Life sciences degree
- More than 5 years of experience in devices clinical research.
- Essential to have knowledge and experience with Device Clinical Trial Applications within Europe.
- Advantage to have knowledge and experience with Pharmaceutical Clinical Trial Applications within Europe.
- Strong oral and written communication skills.
This is one of several positions I am currently recruiting for so do please get in touch for a confidential discussion around your current situation and what your ideal next move would be.
To make an application please feel free to apply via this website, I am also available on LinkedIn to message regarding the role and will accept all invitations that refer to this advert - look for Dominic Mitchell at RBW Consulting.
Please note that owing to the high volume of applications we receive for our roles, if you have not received a response within 48 working hours, do please consider your application unsuccessful.
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