- Clinical Data Manager
Brief Deｓｃｒｉｐｔion of Position
Primary activities include, but are not limited to:
· Receives the study related paper documents from sites or other functional areas, registers them into a work management tool and transfers to data enterer for processing.
· Performs Sponsor Data Entry as applicable per data management plans following entry guiｄｅｌines.
· Participates in the development and change request implementation of data management tools and systems for the clinical trial data management activities under the direction of the Senior/Lead Clinical Data Manager.
· Runs data integrity check reports in accordance with data review plans and relevant SOPs.
· Raises questions to investigational site staff and internal and external vendors,reviews responses and corresponding data corrections to confirm identified issue resolution.
· Responsible for the ｅｘｅｃution of user acceptance testing of data management tools under the guidance of the Senior/Lead Clinical Data Manager.
· Escalates overdue items, including but not limited to outstanding questions and missing visits.
· Assists the Senior/Lead Clinical Data Manager with data management activities to resolve all identified data issues prior to study database lock.
· Complete trial level archiving activities under the direction of the Senior/Lead Clinical Data Manager including, but not limited to, filing of essential documentation.
· Maintains compliance with standard key performance indicators according to process expectations at the protocol level.
· Monitors data quality and cycle-time performance measures to maintain compliance,performs root cause analysis and implements action plans as needed.
· Proactively communicates with Senior/Lead Clinical Data Manager to share project status, risk assessment and outstanding item resolution status.
Qualifications,Skills & Experience
At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.
Knowledge and Skills:
· Self-motivated, excellent in work planning and time management.
· Fluent oral and written English skills.
· Good sense and awareness of regulations and policies.
· Able to work under pressure and in a changing environment with flexibility.
· Good communication skills with the ability to communicate with both the technical and business areas.
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