Clinical Compliance Manager
My client a Global CRO has opened a new vacancy within Clinical department. They are looking to recruit a Clinical Compliance Manager to their team on a permanent basis in Prague.
- Responsible for tracking study activities, milestones and documents including documentation and tracking of budget use or needs for assigned projects
- Maintain up to date training on Standard Operating Procedures (SOPs) and applicable clinical regulations
- Maintain site and internal documentation in accordance with established SOP´s and per applicable regulations.
- Management of external consultants as applicable, including contracts and deliverables
- Ensure reviewed CRF´s go to relevant data management and work with them to resolve any issues, e.g. development of edit checks, reports etc.
- Review relevant monitoring reports from monitors, and their completion of query logs for applicable study sites.
- Review, track and report adverse events and device-related complications in accordance with external regulatory and internal procedural requirements.
- Review and document study deviations (e.g. inclusion/exclusion criteria) and ensure documented actions to address deficiencies as necessary
- Ensure accurate device accountability for assigned investigational device studies.
- Support clinical management in their duties.
- Support other staff with training needs, as applicable
- Identify and support process improvement opportunities and implement best practice
- Facilitate information exchange between European Clinical Programs and US/Global Clinical Affairs Departments, marketing and investigators.
- Requires over 5 years clinical research experience, including monitoring, with clinical studies in European Union
- Requires preferred experience in some or all of the following: Clinical project management, Medical device trial, Study reporting to ethics committees and competent authorities, publications, study communications including investigator meetings, regulatory support of clinical projects, data review, quality management e.g. audits
- Requires experience of pre and post market studies, preferably European
- Requires detailed knowledge of European and international regulations on Good Clinical Practice (GCP), documented training preferred
- Experience with Class II & III medical devices preferred
- Experience with cardiovascular clinical studies is preferred
- Requires university degree or equivalent qualifications in scientific or medical field
- Requires fluent knowledge of English (written & spoken)
More information available on request.
For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070