Sr. Global Librarian - 2448652
With general direction, the Sr. Global Librarian will provide timely guidance to Clinical Science/Business Units Standards Office to interpret data collection requirements into data models of moderate complexity and discuss with Company Clinical Data Standards Governance Board for input and approval. Independently develop and maintain all standard objects, procedures, templates and views for OC standard Global Library.Support or lead a special project (limited in scale and scope) both clinical and non-clinical in nature. With general direction, work with the Clinical Science Units (CSUs) or Business Units (BUs) to understand the data requirements for collection and submission. In this position the incumbent will define the data content and structures for collection, transformation and CDISC SDTM submission requirements in Company Clinical Data Standards of moderate level of complexity. Will also work with the Company Clinical Data Standards Governance Board to ensure that the data models are consistent with Company Standards.
The incumbent will perform impact analysis for proposed modifications to existing domains, permitted choices, and reference tables for discussion with the Company 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. Seek process improvement and incorporation of newly discovered practices towards maintenance of Global Conventions for data modeling/standards and Style Guide for OC/RDC implementation. Contribute to the review of global SOPs and business guidance’s/user guides directly impacting the function and providing input when applicable. Document, develop, test and maintain OC validations and derivations procedures using PL/SQL or SQL on Global/CSU/BU standards. Maintain Form Layout Templates, Extract Macros and Key Templates for use in individual trials. Promote study DCM, DCIs and Procedures to the GLIB if approved for re-use by Company Governance Board. Ensure alignment between OC Global Library Objects and Metadata Repository. Good Knowledge of Company Data Clinical Standards, Data Models and their implementation for database and GLIB development. Train less experienced associates on specific tasks relating to Company Clinical Data Standards and/or Global Library Processes. Subject matter expert in OC and GLIB processes. Act as a consultant to CSU/BU for Company Clinical Data Standards and OC/RDC setup, including validation procedure development.
Required skills:
University or college degree in Life Sciences, Computer Science, Mathematics, Medical Informatics, Statistics, Public Health, Biology or equivalent degree (Minimum BS. ) Minimum 3 years clinical database programming, setup of clinical databases and CRF design experience gained in the pharmaceutical industry or CRO as well as good CDISC understanding and implementation of CDISC Standards. 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. Strong OC/RDC experience; 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 CRF and validation procedure implementation in OC/RD. Strong verbal and written communication skills to work with our global partners and customers. The incumbent must be fluent in both oral and written English.
Contact:
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 Trials Management |
To Apply:
http://us.valesta.com/Submit_Your_Resume.cfm?orderID=2448652
