This position will also evaluate proposed process improvement, performing feasibility assessment prior to incorporation into the Global Conventions for data modeling/standards and Style Guide for OC/RDC implementation. Responsible for authoring global SOPs and business guidances/user guides directly impacting the function and for reviewing and providing input to SOPs and BGs when applicable. Document, develop, test and maintain OC validations and derivations procedures using PL/SQL or SQL on Global/CSU/BU standards, QC revised Form Layout Templates, Extract Macros and Key Templates for use in individual trials prior to production release. Perform impact analysis for modifications to existing standard DCMs as well as effect on DCMs existing at the trial level. Promote study DCM, DCIs and Procedures to the GLIB if approved for re-use by CCDS Governance Board. Ensure alignment between OC Global Library Objects and Metadata Repository. Strong Knowledge of our CDCS including disease areas/BUs , data models and their implementation for database and GLIB development. Train, coach or mentor less experienced associates relating to OC, CDS and/or Global Library processes. Subject matter expert in Data Modeling including disease area(s)/BUs, OC and Glib processes. Act as a consultant to CSU/BU for CCDS, Data Modeling and OC/RDC setup, including validation procedure development. Supervise the work of less experienced associates; may deputize as necessary for supervisor. Timely and accurate development of data models and standard objects in the OC Global Library. Ensure successful mentoring of associates by ensuring transition into the organization, complement formal learning process, and enhance expertise in disease area, specific technical and process areas.
University or college degree in Life Sciences, Computer Science, Mathematics, Medical Informatics, Statistics, Public Health, Biology or equivalent degree (Minimum BS), Fluent English (Oral and Written), Minimum 5 years clinical database programming, setup of clinical databases and CRF design experience gained CDISC Standards in the pharmaceutical industry or CRO as well as the following: Strong CDISC understanding: implementation of Strong understanding of clinical data management systems and/or relational databases as applied to clinical trials: input to requirements for eCRF Development. Strong knowledge of SQL or PL/SQL: development of validation and derivation procedures. Expert in OC/RDC development of objects in the OC global library. Attention to detail, quality, time management and customer focus. Ability to translate technical concepts for non-technical users in the areas of CCDS, Data Modeling, CRF and validation procedure implementation in OC/RDC. Strong verbal and written communication skills to work with our global partners and customers. Train, coach or mentor less experienced associates relating to OC, CDS and/or Global Library Processes.
Traci Palmer, Director Permanent Placement & Specialized Search, Valesta Clinical Research Solutions, A Division of On Assignment, Inc., (Office )1-203-349-4157
Job Type: Employee
Job Status: Full Time
Locations: New Jersey-Northern
Categories: Clinical Data Management
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On Assignment began business in 1985 with the simple vision of bringing top candidates and top employers together. Since that time, On Assignment has leveraged 25 years of putting People First to establish itself as an industry leader.