Clinical Data Associate –III

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Title: Clinical Data Associate –III

Location: Cambridge,MA

Duration: 12 Months

Job Description:

This position is a technical individual dedicated to operational activities related to the technical development, implementation, and maintenance of the Sanofi Genzyme Global Rare Disease Registry web-based electronic data capture (EDC) and reporting technology platform. This position is part of the DM Technical Team which is a sub-group of the overall Registry Data Management group and works alongside the DM Quality team within Data Management.

This position is responsible for coordinating and gathering technical requirements for CRF changes from Registry team stakeholders related to the Rare Disease Registry web-based EDC and reporting technology platform.

This position is responsible for creating and maintaining technical requirements and specifications related to the Rare Disease Registry web-based EDC and reporting technology platform.

This position is responsible for user acceptance testing (UAT) and associated documentation for changes implemented in the Rare Disease Registry web-based EDC and reporting technology platform.

This position is responsible for collaborating with the technical vendor for the Rare Disease Registry web-based EDC and reporting technology platform project meetings, changes, etc.

Knowledge and Skills:

Clinical data management experience (CRF design, data collection, data review, query management)

Experience with EDC systems

Clinical database experience including eCRF/database design and development, system edit check design and development, writing UAT scripts, and conducting UAT

Good working knowledge of software development life cycle (SDLC) and change management

Good working knowledge of industry data standards (e.g., CDASH, SDTM) and how to apply them to CRF design and database development

Ability to work with reporting/analytical tools (e.g., Business Objects) to manipulate data and produce metrics

Strong organizational skills and attention to detail

Strong team work and collaboration skills

Strong communication skills (verbal and written)

Experience with training and developing training materials

Good working knowledge of International Regulations / Guidelines / Good Clinical Practices pertaining to the pharmaceutical industry standards and practices