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Clinical Data Manager

Primary activities include, but are not limited to:
Receives the study related paper documents (i.e. patient diary, adjudication, etc.) 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 SCDM/LCDM
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 SCDM/LCDM.
Escalates overdue items, including but not limited to outstanding questions and missing visits and reports the outstanding items status to the Senior/Lead CDM.
Assists the Senior/Lead CDM with data management activities to ensure all identified data issues are resolved prior to study database lock.
Ensures compliance to standard key performance indicators according to process expectations at the protocol level.
Monitors data quality and cycle-time performance measures to ensure compliance, performs root cause analysis and implements action plans as needed.
Proactively communicates with Senior/Lead CDM to share project status, risk assessment and outstanding item resolution status.
Manual Encoder
Encodes medical terms as applicable per data management plans and Global Encoding Practices Documentation.
Runs encoding check reports in accordance with data review plans to identify encoding issues, including but not limited to unspecified encoded terms, encoded term inconsistencies or departures from entry guidelines.


1. At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Knowledge and Skills:

1. Self-motivated, excellent in work planning and time management.

2. Fluent oral and written English skills.

3. Good sense and awareness of regulations and policies.

4. Able to work under pressure and in a changing environment with flexibility.

5. Good communication skills with the ability to communicate with both the technical and business areas.

Clinical Data Manager

United States
Full Time

Published on 11/02/2021

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