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Monday, May 14, 2012

F/T - Expert Global Librarian - Valesta (NJ)

Expert Global Librarian

The Expert Global Librarian may assist the manager in coordinating and directing Global Library/Modelling activities in support for timely development of standards and study level objects with highest quality to facilitate efficient trial setup. Independently provide timely guidance to Clinical Science/Business Units Standards Office to interpret data collection requirements into data models of high complexity and discuss with our Client’s Clinical Data Standards (CCDS) Governance Board for input and approval. Independently develop and maintain all standard objects, procedures, templates and views for OC standard Global Library. Translate disease area knowledge into both data modeling and technical solutions in order to meet the needs of the franchise/business unit. Manage internal and external relationships. Support or lead a special project (strategic, larger in scale and scope) both clinical and non-clinical in nature. Provide disease area knowledge and data model/technical expertise in the establishment of data standards. Collaborate with Clinical Standards Office and CCDS Governance in design, development and implementation of data models and metadata for new or changed standard pages (Global and CSU/BUs-specific) for collection and submission. Independently define the data content and structures for collection, transformation and CDISC SDTM submission requirements in our CCDS of high level of complexity. Independently work with the Governance Board to ensure that the data models are consistent with our CCDS. Independently perform impact analysis for proposed modifications to existing domains, permitted choices, and reference tables for discussion with CCDS Governance Board. Independently develop, test and maintain all Global/Disease level Library objects needed for clinical studies (DVGs, DVG subsets, Questions, Questions Sets and Question Groups). Document, develop, review and maintain Global Library Copy Groups of DCMs, DCIs, Procedures, Views and DCI books for reuse of standard pages in individual trials.

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.

Required skills:
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

Expanded Opportunities in Valesta!
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.
The industry's first Clinical Support Organization (CSO), Valesta Clinical Research works with top professionals at all career levels, offering contract, project, direct hire and independent consultant opportunities. Utilizing our long standing relationships and industry contacts, Valesta provides expertise in the following specialty areas: Clinical Trials Management (study design & monitoring), Clinical Data, Medical Writing, Biometrics, and Regulatory Affairs.
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