Clinical Evaluation Specialist - Cirencester, UK
Corin, United Kingdom
Job Description
Coring is seek a Clinical Evaluation Specialist who will be responsible for preparation and annual upkeep of Clinical Evaluation Plans and Reports for coordinating the wider team of contributors. The Clinical Evaluation Specialist will contribute to project plans, clinical strategy and clinical investigation planning. The Clinical Evaluation Specialist will collaborate with a cross functional project team and will input to post market clinical follow up (PMCF) activities, conduct clinical evaluations, may participate in assessment of clinical benefit-risk profile and will support post market surveillance (PMS) activities. The Clinical Evaluation Specialist will contribute to monitoring and interpreting results of clinical investigations in preparation for device applications and may serve as a scientific consultant to marketing or research project teams and government agencies.
Corin is a medical device business with innovative robotically assisted platforms for joint replacement surgery. Corin offers a unique combination of clinically proven hip amp; knee solutions and world leading technologies, our OMNIBotics amp; OPS systems utilize intelligent instrumentation to give surgeons the ability to perform patient-specific procedures with high accuracy, with more consistent results and improved recovery rates.
The key responsibilities of a Clinical Evaluation Manager are to:
- Work with external consultants/contractors working on Clinical Evaluations when required.
- Identify and review of clinical evidence from various data sources.
- Prepare summaries and reports to feed into key regulatory documents including clinical evaluation and post market surveillance reports to support new product registrations/submissions and applicable renewal.
- Conduct literature searches and reviews, review national implant registries and compile and summarise relevant data.
- Review Clinical documents for accuracy and to ensure compliance with regulatory standards.
- Post-market and reimbursement activities in global markets including, but not limited to, EU, USA, Australia, Japan, and other distributed markets.
- Provide input into post market surveillance plans of Corin products.
- Collaborate with internal partners, maintain listing of available clinical evidence and generate clinical evidence matrices for key brands.
- Provide direction and guidance to the cross-functional project team on PMCF activities.
- Plan, execute, and finalize deliverables for CE marking products under European Medical Device Regulations (MDR) including but not limited to the Clinical Evaluation Plan and Clinical Evaluation Report within the triple constraints of delivering on time, within budget and scope objectives.
- Research, develop, and write clinical/scientific materials, including background summaries, conclusions/discussion sections, or data summaries for regulatory documents.
- Author and/or critically review and approve a wide variety of regulatory, technical, scientific, and clinical documents, including clinical plans, pre-submission documents, clinical study protocols and reports, integrated summaries, and responses to US Food and Drug Administration/other regulatory agencies or institutional review boards/ethics committees, content posted to clinicaltrials.gov, etc.
- Adhere to Quality Management System (QMS) requirements in line with Corin’s ISO13485 QMS amp; Good Manufacturing Practice (GMP) FDA21 CFR Part 820.
- Ensure that process and timeline requirements for Corrective amp; Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOPs) and in support of Corin’s Global Objectives for CAPA.
Requirements
The ideal Clinical Evaluation Special will have / be;
- A PhD; Advanced Scientific degree, MD or BS/BA in Sciences/Nursing with equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
- Industry experience in Medical Device or Pharmaceuticals including analyzing, interpreting, and summarizing clinical data for internal and external audiences.
- Previous experience as a clinical research associate/field monitor, clinical study project manager, or regulatory medical writer is a plus
- Understanding of European Medical Device Directive (MDD) and MDR
- Experience with post-market clinical follow-up planning and/or post-market surveillance planning is a plus
- Experience with developing registries and utilizing Real World Evidence data to confirm performance and safety of medical devices is a plus
- Experience with regulatory submissions utilizing Real World Evidence is a plus