Senior Clinical Data Coordinator
Posted on: October 12, 2021
Drug Development has an exciting opportunity for a Senior Clinical
Data Coordinator to join the Clinical Data Management team. The
Senior Clinical Data Coordinator will be remotely (home-based)
located anywhere within the United States.
as a member of the project team with primary responsibility for
clinical data review, query generation / resolution and
reconciliation activities to support the delivery of clinical
data according to client quality and integrity specifications, and
project timelines and productivity targets.
of the project Data Management Plan, including the creation of data
acquisition conventions and data review guidelines / diagnostics
specification; and set-up of the data management systems according
to project requirements.
as the technical data management leader on small to moderate
project with technical oversight of data management activities for
the delivery of clinical data according to client quality and
integrity specifications, and project timelines and
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.
ancillary programs (e.g., diagnostics, special listings,
reconciliation discrepancy listings) used to support the review of
clinical trial data.
resolve and track queries to address problematic data identified
during data review activities and apply proper modification /
correction to the data base.
with the dictionary coding and maintenance group to ensure
appropriate process setup and application,
reconciliation of the clinical and safety databases.
reconciliation of central laboratory and/or third party vendor data
(eCRF, eDiary, specialty laboratory, etc.).
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 Drug Development) are
as a reviewer of project documents such as protocols, CRFs (or
eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion
with the development of [Global] Data Management Plans and Quality
Management (QM) Plans that will deliver accurate, timely,
consistent, and quality clinical data.
in the development of the clinical data model and/or database
design and annotate the CRF (eCRF) according to these
in the creation of data acquisition conventions and data review
guidelines / diagnostic specifications consistent with the clinical
data model, [statistical] analysis plans, and CRF (eCRF) completion
/ monitoring conventions.
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
and collaborate with other project and specialty team members
(clinical, programming, statistics, CDM technical support, drug
safety, etc.) to support the set-up, maintenance, and closure of
the data management aspects of the project to ensure consistent,
cohesive data handling and quality.
as client contact for project meetings and CDM status
support business development for data management time and cost
estimates and prepare and present to potential clients on global
data management capabilities.
the training of project staff on project-specific, global,
standardized data management processes.
technical data management competencies via participation in
internal and external training seminars.
literature and research technologies/procedures for improving
global data management practices.
other duties as assigned by management.
degree (life science, pharmacy or related subject preferred), or
certification in a related allied health profession from an
appropriately accredited institution (e.g., nursing certification,
medical or laboratory technology).
lieu of the above requirement, approximately 18 months experience
in related field (e.g. pharmaceutical, laboratory, data analysis)
incorporating approximately one year's clinical data management
experience in addition to the four (4) years relevant work
experience in data management will be considered.
knowledge of drug development process.
of global clinical development budgets and relationship to
of effective clinical data management practices.
knowledge of time and cost estimate development and pricing
knowledge of ICH Guidelines and GCP including international
regulatory requirements for the conduct of clinical development
four (4) years relevant work experience with increasing
responsibility in data management with knowledge of two (2) or more
therapeutic areas.Excellent oral and written communication skills
and demonstrated presentation skills.Working knowledge of the
relationship and regulatory obligation of the CRO industry with
pharmaceutical / biotechnological companies.Demonstrated ability to
work in a team environment and collaborate with peers. Demonstrated
ability to lead by example data management staff.
of clinical trial process and data management, clinical operations,
biometrics, quality management, and systems applications to support
time management skill and ability to adhere to project productivity
metrics and timelines.
Keywords: Labcorp, Durham , Senior Clinical Data Coordinator, Other , Durham, North Carolina
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