Clinical Affairs Specialist - Pharma Company - Winsford, Cheshire but will consider home based - salary is competitive
*Remote interviews and onboarding*
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 '
As a Clinical Affairs Specialist you will provide clinical support to the company's project teams demonstrating a good understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge. The Clinical Affairs Specialist will also be responsible for supporting and monitoring clinical studies to ensure that investigators conduct research within requirements of the clinical protocol and that the research is conducted in accordance with applicable federal regulations / EU Directive and guidelines.
- Delivery of Clinical Evaluation Plans and Clinical Evaluation reports and Post Market Clinical Follow up plans in line with Clinical, Regulatory, R&D, and Commercial objectives.
- Delivery of clinical studies on time and on target by providing administrative, monitoring and data management support required for the conduct of clinical studies.
- Author clinical evaluation reports and support external Medical Writers in the writing of clinical evidence for product approvals.
- Provide clinical regulatory support to cross functional departments such as Marketing and R&D.
- Provide study administrative support for managing all aspects of clinical studies e.g. protocol development, study management, approvals, amendments, reporting and closure.
- Provide data management support as needed e.g. CRF development and assistance with data analysis and reporting.
- Conduct clinical monitoring of study sites to supervise and coordinate clinical studies as needed
- Maintain the Sponsor's Trial Master File.
- Bachelors' degree in relevant scientific discipline. Master's, Nursing, or PhD degree preferred.
- CCRP (Certified Clinical Research Professional), CCRA (Certified Clinical Research Associate) would be an advantage.
- A minimum of 2 years' experience in clinical research in medical device or pharmaceutical.
- Experience of working with European Notified Bodies on product approvals.
- Working knowledge of MEDDEV 2.7.1/4.
- Knowledge of regulations and guidance governing clinical studies including FDA 21 CFR 812, 50, and 56, ICH GCP, ISO 14155, Medical Device Regulation and HIPAA.
- Demonstrated effective verbal, written, interpersonal and presentation skills.
- Position may be office based or remote. Travel up to 20% required.
What should you do next?
If you're ready to apply for this Clinical Affairs Specialist role please upload your CV. Or to discuss this opportunity, or any of our other Clinical jobs further, please give me a call today.
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.