Data Reviewer
Company: Labcorp
Location: Durham
Posted on: May 15, 2022
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Job Description:
Senior Clinical Data Specialist-RemoteReview clinical trial data
in accordance with [Global] Data Management Plans and applicable
standardized data management processes (SOPs, Work Instructions,
etc.) to identify erroneous, missing, incomplete, or implausible
data. --- Run ancillary programs (e.g., diagnostics, special
listings, reconciliation discrepancy listings) used to support the
review of clinical trial data. --- Generate, resolve and track
queries to address problematic data identified during data review
activities. --- Perform aggregate review of clinical data by
patient, site and / or project to identify data trends (patient
safety, compliance, etc.) and / or data inconsistencies that
require further investigation. --- Apply quality control procedures
and checks to ensure data quality standards (client and Labcorp)
are achieved. --- Potentially serve as a reviewer of project
documents such as protocols, CRFs (or eCRF Completion guidelines,
Data Management Plans, Perform Data review utilizing all applicable
documents such as protocols, CRFs (or eCRFs and eDiary) etc. ---
Assist with the development of [Global] Data Management Plans and
Quality Management (QM) Plans that will deliver accurate, timely,
consistent, and quality clinical data. --- Assist in the review of
the database design and annotate the CRF (eCRF) according to the
specifications. --- Create and assist in the data review
guidelines, make sure to be consistent with the clinical data
model, and CRF/eCRF completion / monitoring conventions. --- Assist
in the development and testing of data management system edit /
data validation checks (diagnostics) and special listings /
procedures used as tools for the data review and discrepancy
management activities. --- May assist with the Lead Data Manager or
Lead Data Reviewer to build timelines to meet contracted milestones
by communicating with leads in different disciplines and the full
project team as necessary. --- Knowledge of Data Management tools,
systems, and processes. --- Ensures service and quality, meet
agreed upon specifications per the DMP and scope of work in the
budget. --- Inform Lead Data Reviewer of overages in budgeted units
and assist in Change Order Log process, if applicable. Perform
quality control on data management activities as appropriate to
include, but not be limited to all study documentation, query
generation and integration; to ensure that internal and client
quality standards are achieved. --- Support and action client or
internal audits as appropriate and resolve all issues within an
appropriate timeframe. Address client comments with the study team,
as appropriate. --- Mentor / Coach in training of project staff on
project-specific, global, standardized data management processes.
---Performs other related duties as assigned by management.
4 to 6 years of Clinical Data Management. --- Some knowledge of
clinical trial process, DM, clinical operations, biometrics, and
system applications to support operations. --- Time management
skill and ability to adhere to project productivity metrics and
timelines. --- Ability to work in a team environment and
collaborate with peers. --- Good organizational ability,
communication, and interpersonal skills. --- Team working skills
and good collaborator skills. --- Knowledge of medical terminology
is preferred. --- Knowledge of science or a scientific background
is preferred. --- Good oral and written communication skills.
Preferred: --- Through knowledge of Covance, the overall structure
of the organization and Standard Operating Procedures (SOPs). ---
Two or more years of Electronic Data Capture experience. ---
Knowledge of Labcorp and the overall structure of the
organization.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in
its employment practices due to an applicant's race, age, color,
religion, sex, national origin, sexual orientation, gender
identity, disability or veteran status.
For more information about how we collect and store your personal
data, please see our - -
Keywords: Labcorp, Durham , Data Reviewer, Other , Durham, North Carolina
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