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Major Responsibilities
1.Assist to build up and maintain the training system and procedures of China Clinical Operations according to the company policy and Local SOPs. The training system is mainly for providing trainings to Clinical Operations team members. Set up the training procedures and guarantee the procedures are well conducted.
2.Facilitate and support quality and risk management activities in clinical trails (at study level and site level).
?Assist to conduct quality oversight activity and identify quality improvement actions (e.g. corrections and CAPA) based on the results; for example, execute and document quality oversight visits at the Clinical Investigator sites.
?Monitor compliance risks to evaluate if all defined Quality System processes are effectively deployed and continually kept up at study level.
?Help to educate, guide and influence clinical research management and staff on best quality and compliance practices.
?Assist to quality related procedures as assigned.
?Provide consultation and inputs for process improvement in terms of quality oversight and quality review activities.
?Support clinical operation head with the execution of assigned clinical quality responsibilities.
?Lead the team create annual ASV/TMF QC plan and conductions, as well as the following issue tracking/CAPA mechanism.
3.Design and deliver the quality related (GCP) training program in collaboration with key business partners to ensure all staff are clear about the quality expectation and standard of processes, industry and regulatory;
4.Maintain knowledge of latest Regulatory Intelligence and Industry initiatives on clinical research;
5.Drive Continuous Clinical Trail Quality Improvement
?Be an expert in corrective and preventive actions (CAPA) management.
?Lead and collaborate with the business partners in timely developing robust CAPA/risk mitigations.
?Monitor the progress of CAPA & risk mitigations along with the implementations and confirm effectiveness of these actions, e.g. by performing QC checks or special investigations.
?Identify potential gaps or opportunities for improvement and recommendations to improve the QMS (i.e. effectiveness of CAPAs, proactive identification of quality issues, appropriate metrics for QMS health etc.).
?Assist to generate and/or provide metrics, status and trend reports and other information, as required by management.
?Cooperate with team leaders of Clinical operations to develop or update SOPs of China Clinical Operations under the consideration of business requirements and regulations.
6.Support AD of Clinical Trial Quality & Training with the execution of assigned clinical quality and training responsibilities.
Qualifications
1.Job Required Competencies
?Knowledge of the overall drug development process
?Ability to motivate professional colleagues and stakeholders
?Conflict resolution/management and negotiation skills
?Ability to independently plan, organize, coordinate, manage and execute assigned tasks
?Experience of the key customers’ business processes and practices
?Excellent working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development
2.Education / Qualifications
?Minimum bachelor’s degree in medical pharmacology or Life/Biological Sciences, advanced degree preferred
?Experience in clinical research (min. 8 years) & quality management/ quality control /Training (min. 2 years).
?Experience in risk assessment and mitigation planning.