Company: Ivory Systems
Posted on: May 16, 2022
Manager, Data Management
Position Summary:Maintain a project-level perspective on data
management issues, activities and deliverables. Oversee the
Contract Research Organization (CRO) and third-party vendor
processes involved in developing data collection systems, data
cleaning and providing data deliverables conforming to global CDISC
otthe Data Management Department on project teams and manages flow
of data from collection to submission. Work with representatives
from all functional areas to develop and maintain consistency,
accuracy and quality of data across therapeutic areas.
Key Job Responsibilities-
- Works collaboratively with CROs and third-party vendors to
design database, define quality specs, and resolve data
- Assists in developing and maintaining DM standards and
processes for both in-house and CRO studies in accordance with
applicable standard operating procedures (SOPs) and GCPs.
- Provides consultation, leadership, and expertise to CRO DM and
project teams on Data Management functions.
- Acts as the Data Management lead for all assigned protocols,
including contributing to the development and implementation of
- Ensure standard processes are followed by all CROs for data
management activities. Train CRO personnel on current
- Uses software applications to monitor and evaluate CRO
performance (e.g. query status, data trends, detecting outliers and
- Acts as a resource to the contract staff to identify problems
and propose solutions to maintain projects within designated
- Proactively identifies and implements opportunities for process
- Provides expert review and help in the development of
CRF/eCRF/eSource design specifications, validation specifications
and report design, etc. Works with external service providers to
help troubleshoot and resolve problems.
- Ensures the consistency of CRF design and coding across studies
- Contributes to protocols, clinical study reports, Investigator
Brochures, Statistical Analysis Plans, INDs and other regulatory
- Prepares submission ready Electronic Case Report Forms (eCRFs)
to support electronic submissions.
- Reviews SOW, provides input and ensures consistency across
programs for Data Management activities to be outsourced to
- Manages third party vendors' (e.g., CROs, EDC/eSource, and
ancillary) processes, and local/central laboratories on defined
data standards, content specifications, and timelines for
- Communicates and interacts with CRO vendors to ensure that
project timelines are met with quality.
- Provides status reports on the progress of projects/programs to
- Ensures data management related presentations for
Investigator's meetings adhere to requirements.
- Provides input in the development of departmental and global
- Serves as project team member and works closely with
biostatistician and programmer to provide quality
- Other tasks assigned by Associate Director, Director or Sr.
Director of Data Management Requirements-
- Bachelor's degree with a minimum of 3 years of experience in
data management within pharmaceutical industry.
- Must have prior Project Management experience
- Esource Experience, nice to have but other comparable
experience will be helpful
- Strong understanding of medical concepts and terminology
- Knowledge of CDISC and industry standards
- Strong working knowledge of data management practices and
applicable global regulatory requirements
- Strong working knowledge of electronic data capture systems,
eSource and familiarity with regulatory guidelines on use of
- Strong computer skills with demonstrated experience in working
with the Microsoft suite of programs.
- Know how/when to apply organizational policy or procedures to a
variety of situations.
- Strong oral and written communication/presentation skills.
- Technical Acuity preferred and an openness to learn
Keywords: Ivory Systems, Trenton , Data Manager, Executive , Princeton, New Jersey
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