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*job description*:it is critical that, for all sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained.
the ccqm position has a significant impact in achieving those objectives.under the guidance of the regional director, clinical quality management (rcqm), the ccqm oversees all cqm activities in the respective country/cluster.the role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives.
in addition, the ccqms support audits, inspections as well as quality control and local training activities.qualifications:- bachelor's degree or equivalent in relevant health care area.
*experience*:- a minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments.
experience in country operations preferred.- deep knowledge and understanding of clinical trial processes, good clinical practices and other clinical research related regulations.- solid track record of initiating, planning and delivery of projects and knowledge of project management practices.- demonstrated experience in leading cross-functional teams.- ideally, experience in clinical quality management including quality control activities, process management & improvement.- ideally, experience in managing audits and inspections.- ideally, experience in coordinating and delivering training sessions.
*skills*:- superior oral and written communication and leadership skills in an international environment.
excellent project management and organizational skills.- excellent teamwork skills, including conflict resolution expertise and discretion.- ability to analyze, interpret, and solve complex problems.- ability to think strategically, objectively and with creativity and innovation.- ability to proficiently interact with all levels of clinical research management and exert influence to achieve results.regulations & processes:- local expert for ich-gcp and local regulations (incl.
impact assessment of new/updated local regulations on local processes).- in close collaboration with local country operations management, manages the local network of owners / subject matter experts (smes) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local standard operating procedures (sops) / work instructions (wis).- local expert for any quality-related local processes.- identifies process gaps / opportunities for process improvement and properly escalates to rcqm and/or global process owners (if necessary)