Description:
CMR is an exciting and evolving company to be joining right now. Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals.
Responsibilities
- Contribute to the development & delivery of appropriate evidence generation & dissemination plans for clinical studies
- Contribute to the delivery of clinical studies in compliance with regulations & SOPs
- Provide input into clinical trial protocols, informed consents, investigator brochures
- Support with clinical trial reports writing and communication reports for assigned studies and study close out reports
- Contribute to data monitoring activities and support sites and/or research organizations with collection of clinical data
- Support with communications ( Sites / medical writers / PIs) and clinical data organization for publication
- Support clinical scientific discussions with regulatory agencies & notified bodies
- Support internal and external communications related to patient safety reporting
- Identify, communicate and mitigate risks in clinical data collection and monitoring
- Develop and implement data quality control measures to ensure that all data is accurate, complete, and consistent
We’d expect you to be willing to turn your hand to anything within the Medical Affairs remit that helps the team deliver its objectives.
About You
- Understanding of research science & processes, GCP & regulatory requirements
- Experience in healthcare & clinical research and healthcare market or regulatory environment
- Ability to provide scientific research input across clinical studies
- Knowledge of principles of clinical data collection and reporting including Serious adverse event (SAE) reporting
- Life sciences degree
- Good clinical practice training
- Familiarity with / training ISO 14155
- Previous experience in clinical data monitoring of clinical trials
- Strong clinical data tabulation, analysis and reporting skills
- Previous experience working with Contract Research Organizations and clinical sites
- Preferably previous experience with Real World Data and post marketing surveillance