A leading pharmaceutical company in Princeton, NJ requires **"Clinical Data Coordinators“**.
Most important criteria is at least *2-3 years of data review experience in EDC* - Rave or InForm experience is a BIG PLUS.
Location: Princeton, NJ
+ Primary responsibility: Clinical data review, query generation, resolution and reconciliation activities to support the delivery of clinical data according to client quality and integrity specifications.
+ Potential to assist in the development of the project Data Management Plan, including the creation of data acquisition conventions and data review guidelines I diagnostics specification; and set-up of the data management systems according to project requirements.
+ Potential to serve as the technical data management leader on small projects with technical oversight of data management activities for the delivery of clinical data according to client
quality and integrity specifications, and project timelines and budgets.
Essential Job Duties:
+ Review clinical trial data in accordance with Global Data Management Plans and applicable SOPs, Work Instructions to identify erroneous, 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 and apply proper modification I correction to the database
+ Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and application
+ Perform reconciliation of the clinical and safety databases
+ Perform reconciliation of central laboratory and/or third party vendor data (eCRF, eDiary, specialty laboratory, etc.)
+ 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 are achieved
+ Potentially serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), monitoring conventions, CRF (eCRF) completion guidelines, 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 development of the clinical data model and/or database design and annotate the
CRF (eCRF) according to these specifications
+ Assist in the creation of data acquisition conventions and data review guidelines I diagnostic specifications consistent with the clinical data model, [statistical) analysis plans, and CRF (eCRF) completion I monitoring conventions
+ Assist in the development and testing of data management system edit I data validation checks (diagnostics) and special listings I procedures used as tools for the data review and discrepancy management activities
+ Potentially interact 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
+ Potentially serve as client contact for project meetings and CDM status updates
+ Support the training of project staff on project-specific, global, standardized data management processes
+ Perform other duties as assigned by management.
+ Minimum two (2) years relevant work experience with increasing responsibility in data
management with knowledge of one (1) or more therapeutic areas.
+ Demonstrated time management skill and ability to adhere to project productivity metrics and
+ Potential ability to lead by example data management staff