职位描述

职位描述： General?Ensure that all data components are conducted in compliance with GCP, relevant SOPs, and regulatory requirements.?Ensures Conformance to Pfizer Data Standards.?Actively participates in monthly project review meetings.?May participate in Therapeutic Area (TA) specific process improvement initiatives.Hands-on data management responsibilities (Data Manager):?Create and implement the Data Management Plans (DMP) to ensure data completeness and accuracy.?Set-up and test data review listings to verify the quality and completeness of data as specified in DMP.?Ensure timely set-up of clinical data acquisition and management tools and data validation.?Maintain study tracking to ensure timely CRF retrieval, data entry and data cleaning activities.?Perform data cleaning activities including discrepancy management (review of errors from electronic checks) and review of data listings to verify quality and completeness of data.?Ensure integrity of clinical data and update database by issuing and resolving DCFs as necessary.?Reconcile the patient database with the Serious Adverse Event database.?Document all efforts of data management and file all responsible documents.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： 临床数据分析员

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