Clinical Study Manager - Pharma Company - UK Wide - salary is competitive
*Remote interviewing and onboarding process*
This excellent role sits with a leading pharma company who specialise in innovative and technology advanced products in wound care.
- This company are committed to attracting talented people and encouraging their career development. We recruit candidates based on our core values of 'Care, Fair and Dare '
An exciting opportunity has arisen for a Clinical Study Manager, on a 12 month Fixed-Term Contract. The role can be based from office, or home-based, and you will be responsible for the development and execution of human subject clinical studies, from inception to closeout, for their whole global product range.
- Development of clinical plans and strategies; and delivery of high quality clinical trials.
- Development of all trial-related documentation, including: protocol, investigator brochure, consent documentation, project plans, timelines, etc.
- Budget management for assigned projects.
- Coordinate and oversee clinical studies to support regulatory submissions (e.g. PMA, 510(k), Technical Files, Design Dossiers, and Post Market Surveillance); assist in preparation of clinical study reports, regulatory documents and submissions.
- Actively interface with various internal and external stakeholders including Key Opinion Leaders, clinical research staff, Marketing, Regulatory, R&D, Legal, Quality as the subject matter expert for GCP.
- Bachelor's degree in life sciences or health-related field or equivalent education and experience
- Experience as a Clinical Research Associate, Clinical Project Manager or equivalent position
- Self-motivated individual who can manage multiple tasks and priorities in an efficient manner.
- Experience in the medical device field preferred; experience in the pharmaceutical industry considered
- Demonstrated track record of compliance to regulations governing human clinical research.
- Ability to identify investigational sites and investigators
- Advanced knowledge and application of industry standards and best practices in clinical trial management and applicable country regulations (US FDA, ISO, ICH, etc.)
What should you do next:
To discuss this Clinical Study Manager role, or any of our other live jobs within Clinical Research, please give me a call today. Or if you're ready to apply you can do so with your CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.