Clinical Data Manager Job

Date: Feb 16, 2019

Location: Colombia, CO

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Requisition ID: CLI008326

Position Overview:


Under the direction of the
applicable management, the Clinical Data Manager (CDM) is responsible for
executing end to end data management activities pertaining to clinical trials,
including but not limited to; data management tool and system development,
validation and maintenance, data collection, data integrity review and
reconciliation, query management, medical coding, and database lock
preparation, in compliance with MSD Standard Operating Procedures (SOPs) and
ICH-GCP guidelines.



 


Primary activities include, but
are not limited to:



 


§  Receives the study related
paper documents from sites or other functional areas, 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



§   Execute data validation
activities in accordance with 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.



§  Assists the Senior/Lead CDM
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 SCDM/LCDM including, but not limited to,
filing of essential documentation.



 



Qualifications

Education:


At least B.A. or B.S. degree, Nursing, Veterinary, Dentistry, Bacteriology, Pharmaceutical Chemistry or Biomedical Engineering
.



 


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.






Job: Clinical Data Management
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Clinic, Database, Medical, Engineer, Data Management, Healthcare, Technology, Engineering, Data

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