Clinical Data Manager Job

Date: Jun 26, 2019

Location: Bogotá, CO

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Requisition ID: CLI008449

At MSD, we seek to discover
and champion the latest, most promising advancements against the world’s
greatest health challenges. To accomplish this, we are willing to invest in
solutions that take us in directions we’ve never explored before. Because we’re
on a relentless quest for cures. And we’ll be known differently in our industry
because of it



 


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. Also, Biologist, microbiologist with clinical experience of 1 year.



 


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, Microbiology, Medical, Engineer, Healthcare, Technology, Science, Engineering

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