职位描述

职位描述： Study management responsibilities (Lead Data Manager):?The single point of contact for study team on data management?Accountable for the implementation of all data activities for the responsible studies.?Review protocols to ensure the data collection, database and reporting requirements can be met and are standardized?Provide technical oversight, guidance and coordination for all the data management activities?Produce and track metrics as a tool to ensure that data management deliverables are on target.?Implement and promote the use of consistent, efficient and quality processes to meet timelines and deliverables.?Assist in the development and implementation of new TA clinical data standards?Ensure clear and timely communication with study team members to enable continuous improvements during the study?Proactively plan, assess workload, and prioritize activities to ensure study timelines are met?Ensure lessons learnt during the course of the study are documented and shared with other study teams to facilitate cross-study learning.Technical Skill Requirements?Demonstrated knowledge of clinical development process including knowledge and understanding of the principles of GCP?Demonstrated knowledge of data management processes and principles in area of responsibility.?Works independently, receives instruction primarily on unusual situations?Ability to organize tasks, time and priorities; ability to multi-task?Ability to communicate effectively and appropriately with internal & external stakeholders, locally and globally?Ability to work in ambiguous situations within teams to identify and articulate complex problems?Demonstrated knowledge of clinical development and regulatory submission processes and requirements.?Knowledge/proficiency/understanding of technologies to support data acquisition, computerization and data validation, computer systems life cycle technology?Strong understanding of the state-of-the-art technologies to evaluate and leverage them into improved business processes for worldwide deployment and adoption.Qualifications (i.e., preferred education, experience, attributes)? Bachelor degree or equivalent in a natural/medical science, data management or related discipline.Preferred Additional Experience?Working knowledge of clinical development process, understanding concepts of Phase I-IV and principles of study design?Previous experience within a data management role, understanding key processes and principles associated with role including CRF design, database set-up, edit check specification, DMPs and data cleaning activities?Knowledge of clinical trial database and its applications?Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.) 职能类别： 医药技术研发管理人员

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