Position: Senior Data Manager

Position Description:

The Senior Data Manager coordinates all data management tasks for a given clinical study or studies involving investigational or non-investigational drugs, biologics and devices and acts as the primary point of contact for all data management activities for a given clinical study or studies.

Responsibilities Include:

• Reviews and understands study protocol and assures consistency internal to the protocol and the goals of the study/program
• Designs Case Report Forms (CRF) and coordinates review by project team
• Communicates with client regarding CRF design issues
• Coordinates the printing and shipping of CRFs
• Develops Data Management Plan (Edit Check Specifications, CRF completion guidelines, and Self Evident Correction Guidelines, etc) for each assigned clinical study
• Coordinates the review of clinical trial data, identifies erroneous, missing, incomplete, or implausible data and writes queries
• Understands the fundamental needs for and uses of relational databases and can work with IT Applications to ensure proper clinical database design
• Troubleshoots system problems, resolve related issues, and recommend appropriate modifications
• Understands the fundamentals of management of central laboratory data and other types of electronic data
• Ensures that all external data is imported into the database and define quality acceptance criteria for electronic data
• Oversees coding of adverse events and medications
• Assigns tasks to data reviewers
• Coordinates with Project Coordinator to assure timely submission of CRFs and queries from sites
• Represents Data Management at project team meetings and provides updates to project team on status of CDM tasks
• Communicates with Project Manager and Project Coordinator regarding project team and/or client issues
• Ensures that all preparatory steps to lock a clinical database are accomplished and database is locked successfully and within the timelines
• Ensures adherence to all timelines associated with data management
• Assures that the data management needs of project(s) are met, reporting all areas of concern to the Manager of CDM Department to assure timely and appropriate resolution of clinical team and/or client issues
• Assures that all aspects of data management are performed in accordance with client requirements and applicable corporate SOPs/WPDs, Federal Law, Guidelines and ICH standards, as appropriate
• Supervises, coaches, and develops staff
• Ensures that required training for directly supervised staff members is identified, provided in within a reasonable timeframe, and is current
• Other relevant duties assigned for which the incumbent is qualified

Requirements:

• Bachelor’s degree in medical or healthcare-related science, MS or above welcomed
• An advanced scientific degree (M.S., PhD.) or clinical certification (R.N., M.D.) is desired
• At least three years of clinical data management experience in a pharmaceutical company or CRO or equivalent education and experience
• Oracle Clinical database experience preferred
• Supervisory experience preferred
• Demonstrated strong skills in the management and resolution of data-related issues
• Demonstrated strong communication and analytical skills
• Demonstrated well organizational skill and able to prioritize multiple tasks
• Be able to manage multiple projects, as necessary
• Strong team-building skills and the ability to work successfully in a team environment
• Knowledgeable about the Federal regulations and requirements governing the conduct of drug, biologic and device studies including, but not limited to, GCP and ICH requirements
• Experienced in developing and leading effective presentations in public settings
• Demonstrated verbal and written communication skills in both Chinese and English.
• Demonstrated computer skills including MS Office and Internet usage.

*_*有意者请发送简历至：
电话：+86（21）3366-5188～90
应聘Email：[email]shanghaihr@grs-cro.com
地址：上海市黄浦区南京东路299号宏伊国际广场1201室，200001
总公司网址： www.grs-cro.com
上海分公司网址：www.grs-cro.com.cn