Ref #: 28792

Employment type: Permanent - Full-Time

Location: United States - remote

Posted: 10-May-2021

Description

Are you a clinical research professional with a love for SDTM?? Are you looking for a new challenge? ICON/DOCS has the perfect position for you! We are looking for a candidate with SDTM experience to join our team as a Data Standards expert!

Position Summary:
• Develop and maintain SDTM library standards used across all therapeutic areas.
• Delivering data standards such as SDTM, Controlled terminology and mapping metadata
• Configures standards to specific needs and requirements of Therapeutic area, Compound or Disease area generating the expected efficiencies through optimal adoption and reuse of standards.

Responsibilities:
• Recognize, exemplify and adhere to the client standards
• Read, ensure understanding and adhere to all assigned SOPs and working procedures (as appropriate).
• Ensure all work performed is of high quality, compliant with Good Clinical Practice, ICH Guidelines and all applicable laws and regulations.
• Implement the standard content in the data delivery tools, creating efficiencies within the trials, consistency across the trials and automating the CRF build and the data flow from collection to SDTM
• Support the following activities:
-Study Data Tabulation Model (SDTM)
-Annotated Case Report Forms (CRFs)
-Support the data transfer agreement (DTA) standards with SDTM
-Data Review Model (DRM)
-Mapping metadata from data collection (CRF and DTA) to DRM
-Mapping metadata from DRM to SDTM)
• Implements standard content in the delivery tools compliant to the industry standards and health authority regulations, meeting best computer system validation practices where applicable.
• Annotates the CRF with SDTM metadata and collaborates with team members on the correctness of the annotated case report form meeting submission, scientific and operational requirements and guidelines. 
• Defines and maintains the standard clinical data collection and the clinical data delivery standards for use in clinical trials. 
• Maintains the data collection and delivery and metadata standards at a master level to meet additional scientific or operational requirement supporting the R&D portfolio. Ensuring formal change management control and versioning of the standards is applied and adhered to.
• Governs formally all the changes to standards and manages multiple versions in line with adoption needs of the clinical trials and drug development programs. 
• Pre-configures the standards in line with the specifications of the data lifecycle plans, while maintaining the traceability and lineage of the data. Documents and manages correctly the lineage between master standards and the many pre-configured standards.   
• Provides the necessary support to the clinical data standards team and the clinical analysis team who facilitate the consistent adoption of standards in the studies (internally or outsourced to a CRO).  

Qualifications:
• University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
• Experience with coding and running SAS programs
• Knowledge of Rave eDC (Medidata Solutions) is a preferred
• Expertise with CDISC standards: SDTM, CDASH, Controlled terminology and define.xml. 
• Experience with SAS LSAF and Pinnacle 21 is a plus
• 2 years of relevant operational experience in clinical data management or standards
• Relevant operational experience in clinical data standards is preferred 
• Experience in prioritizing and managing multiple tasks simultaneously 
• Outstanding written and verbal communication skills in English

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.