CLINICAL RESEARCH MANAGER | MEDICAL DEVICE AND IVD

Position Title: Clinical Reseach ManagerClassification: Full TimePlace of Work: Remote with some in-person activities. Based in Spain, Portugal, or the United Kingdom.SUMMARY The scope of a Clinical Research Manager is to develop the clinical operations and coordinate clinical studies related to medical devices and in vitro diagnostics devices following the GCP and the European and local regulations and guidelines. The duties involve managing from the start-up to the Close-Out stage, including the supporting the protocol and case report form design, submissions to Ethics Committees and Competent Authorities, clinical on-site monitoring and maintaining close contact with study site coordinators and investigators. RESPONSIBILITIES • Initiating and managing clinical projects in accordance with all relevant guidelines, legislation, and sops. • Monitoring the progress of the clinical trial against the project plan and performance indicators for quality and budget. • Identifying risks, and developing and implementing plans to mitigate risks in collaboration with team members and other stakeholders. • Acting as a daily point of contact for the sponsor and members of the project team. • Developing research-specific documents, trial master files (TMF) and electronic trial master files. • Reporting progress to the internal project team and stakeholders. • Negotiating contracts with research centers and suppliers. • Managing project finances in accordance with the sponsor contract and budget. • Providing input for proposals and budgets and in bid defense meetings.• Project management. • Periodically review the context and requirements of the organization's stakeholders. • Take part in the Management Review. • Provide the new employee with the onboarding manual and facilitate access to necessary tools and systems. • Coordinate the new employee's initial training program. • Evaluate the employee's current position and growth within the organization.• Schedule and hold an evaluation meeting with the employee to discuss the evaluation results, providing additional insights and perspectives on the employee's performance. • Review the employee's training plan and assess the effectiveness of previous training actions.• Participate in a collaborative dialogue to define career goals, development opportunities, and performance improvement plans if necessary. • Establish the consultants personal training plans. • Evaluate the effectiveness and impact of the training program, analyzing feedback and performance improvement observations, and taking necessary actions to enhance the program. • Adhere to all QMS procedures and demonstrate a commitment to continuous improvement.QUALIFICATIONS• 1-3 years of professional experience as a CPM with medical products, medical devices or IVDs. • Working knowledge of GCP. • Advanced verbal and written English (C1-C2 certificate or equivalent knowledge). • Fluency in more than one EU language is desirable. • Bachelor’s degree in life sciences.• Masters qualification in life sciences.• Ph.D. in medical discipline is preferred About MDx CROMDx CRO is a leading Contract Research Organization specializing in in vitro diagnostics (IVDs) and medical devices, headquartered in Europe. We offer a comprehensive range of services, including regulatory consulting, clinical research, and quality assurance, helping clients navigate the complexities of bringing their products to market in full compliance with global regulatory standards.Why Join MDx CRO?At MDx CRO, we provide a dynamic and challenging work environment within a rapidly growing company renowned in the MedTech and IVD industry. We are committed to fostering professional development and offering our employees opportunities for career growth and personal advancement.We operate on five core principles:Make it POSSIBLEMake it WIN-WINKeep IMPROVINGKeep GROWINGKeep it DIVERSEOur VisionTo democratize access to world-class regulatory and clinical strategies, ensuring safer and more effective medical technologies for all.Our MissionWe are pioneers of emerging technologies, navigating uncharted territories to redefine the future of the medical sector.Grow with Us!