| Job Description:
KEY ACCOUNTABILITIES: Rank Major duties & responsibilities End results expected 1.Primary contact between CDM and clinical study teams. Liaises directly with internal customers (Clinical, Biostatistics, Quality Assurance, Regulatory Affairs) and external customers (affiliates, CROs, clinical research units) to cover all aspects of data management for assigned studies. Negotiates responsibilities and timelines. Ensures departmental companion groups (i.e., Coding,CRF design, SSD, PM, DMS) are consulted appropriately on study decisions. Implements and oversees processes and coordinates activities in conjunction with the study team and Project Leader. Proposes solutions for data management issues that arise during the conduct of a study Clear and effective Data Management Plan for each study. High Quality Database locked per timelines. Interim deliverables, such as interim analyses databases, delivered according to team specifications and timelines. 2.In charge of the development of protocols, CRFs, Data Management Plan, Data Validation Plan, Data Review Report as per company standards. Assures that data management standards are followed for the studies in charge.High quality CRFs, Data Management Plan, including Data Validation Plan, and Data Review Report. 3.Coordinates CDM study teams (Clinical Data Coordinators, contractors) assigned to support studies.Effective leadership of CDM study team. Clear assignment of individual tasks and adequate use tracking tools to monitor study progress. 4.Continually evaluates CDM processes and applications for improvements. Participates in working groups to develop and implement new applications and procedures. Maintains knowledge of current regulations and technologies related to the data management function. Deputizes for the Project Leader Data Management, when appropriate. Participates in the implementation of department initiatives. Best practices applied to all aspects of CDM project/ study activities. JOB-HOLDER ENTRY REQUIREMENTS: Knowledge and skills: Clinical Data Management System experience (e.g., Clintrial, Oracle Clinical) and understanding of database/programming concepts preferred. Expert in the use of Data Management applications and database/file structures; able to use SQL, SAS and other programming/query languages; able to acquire and apply new technical skills. Knowledge of industry standards and practices. Understands the clinical development process. Communicates effectively with study teams and departmental associates. Establishes rapport and collaborates with others both inside and outside the company; builds constructive and effective relationships; demonstrates flexibility through effective negotiations, can be direct yet diplomatic. Anticipates problems, issues, and delays, and proactively works to minimize the impact; follows through on all tasks and ensures high quality results. Consistently meets deadlines according to accepted levels of quality, paying attention to details. Learns quickly when facing new problems; uses rigorous, objective logic and methods to solve difficult problems with effective solutions; follows implementation plans through to completion. Sets clear assignments as well as clear objectives and measures; monitors process, progress and results Formal education and/or experience required: Bachelor degree, preferably in a life science or mathematics-related area (e.g., computer sciencecs) or equivalent experience(at least 5 years) in clinical data management. Oral and written English communication skills. Knowledge and skills desirable but not essential: Knowledge of sanofi-aventis SOPs. Remote management experience. Management of outsourced activities If you are interested in this job, please be free to contact us by teachcn@yahoo.com.cn |
