CLINICAL DATA MANAGEMENT SPECIALIST/PROGRAMMER (SQL FORMS)
Salary: DOE
Location: Bergen County, NJ

~Provide Data Management Project Management to the study team by overseeing all tasks within Data Management.
~Oversight/creation of Data Management Plan consisting of multiple documents that define how data is captured, processed, cleaned, and closed out.
~Coordinate and oversee data collection processes, tools, and deliverables for clinical trials from initial study conception to closeout.
~Partner with study team members, other staff, and external vendors, to define how data is captured, processed, cleaned and closed out, ensuring efficient product delivery while maintaining high quality standards.

DESCRIPTION
~Manage database design/EDC activities and approval of related deliverables: DB Build specs, Electronic Data Transfer specs, DE Screen testing, Edit Check development/testing, DB release date, etc*
~Develop and revise Data Management Plan ensuring input and approval from relevant functions. The plan includes, but is not limited to: CRF Completion Guidelines, Quality Control Plan, Serious Adverse Event Guidelines, Edit Check document, and Coding Guidelines. Ensure all activities in the Data Management Plan * either by *hands-on* activity or through coordination * are completed.
~Analyze the results from quality control activities (e.g., metrics, discrepancy/query analysis, data audits) to ensure that data quality is not put at risk and apply remediation activities if/when required.
~Develop, define, and manage DM related timelines, deliverables, and performance metrics with study team, other staff and external vendors. Critically assess and forecast clinical trial progress and communicate expectations/deliverables in terms of study milestones.
~Review draft protocol concept sheet and protocol for consistency and assess the implications on DM activities (e.g., CRF design/ EDC, identifying vendor data [PK, Labs, MRI, etc*]). Coordinate the design of these respectively with input from data operations and study team.
~Review study financial budget * for DM deliverables only * to ensure that the study deliverables of *high data quality, within budget, and according to plan/specifications* are met (e.g., original contract budget, change orders, out of scope).
~Participate in kick off meetings and/or study team meetings to discuss logistical aspects of trial (e.g., trial location(s), status updates, timelines, data delivery expectations, DSMB involvement etc*).
~Support other function activities (e.g., Statistical Analysis Plan (SAP), Tables, Figures, Listings (TFLs)/Tables, Listings Graphs (TLGs) and Clinical Study Report (CSR) review/input).

REQUIREMENTS
~Bachelor Degree in Science or related field is required.
~Highly desirable experience in set up and management of EDC studies
~Thorough knowledge and understanding of GCP, the clinical research drug development process, clinical study trials, and the role of Data Management and Project Management activities.
~In-depth knowledge of Data Management procedures, process, and best practices.
~Awareness of CDISC and influence on standards.
~Experience in management of Phase I-IV studies, managing and coordinating projects from start to finish with Data Management
~Highly developed Project Management skills.
~Proven experience in managing CROs, Functional Service Providers, and Technical Vendors.
~Thorough knowledge of the clinical trial data collection applications, systems, and specifications used internally and by partner CROs, Functional Service Providers, and Technical Vendors.
~Understanding of database designs and desired outputs needed for reliable statistical analysis and other reporting-related activities.
~Familiarity with best clinical practices to ensure appropriate advice is provided to team * both internal and external * on proper/preferred practices covering data capture, processing, cleaning, and close out activities during the clinical trial.
~Ability to critically assess and forecast clinical trial progress * through metrics, timeline management, etc... * so that remediation activities can be applied if/when required
~Understanding of medical coding processes, in particular use of MedDRA and WHO dictionaries.
~Knowledge of the development of clinical study protocols and amendments.
~Knowledge of CRF development and an understanding of the relationship between data collection, database design, and data delivery to Biostatistics
~Understanding of Serious Adverse Event (SAE) handling and reconciliation requirements