Clinical Data Specialist Temporary contract 6 months

Job Description

Primary Function of Position:

The Clinical Data Specialist is principally responsible for building eCRF from end to end as well as analyzing complex clinical data sets to optimize workflow and to ensure that the data gathered is accurate and reliable within his/her assigned projects in the region covered by Clinical Affairs EMEIA.

Roles and Responsibilities:

• Build eCRF studies from end to end in Medidata Rave EDC including derivations, dynamics and edit checks
• Perform post production changes / Migration
• Coding custom functions with C# for Rave studies is a plus
• Assist in testing and evaluating new upgrades to technologies
• Conduct and coordinate the validation and testing (UAT) of the clinical database
• Clinical Data Reports: Develop scripts to produce study-specific clinical data status reports as required.
• Review clinical data on an ongoing basis to ensure compliance of data Integrity and quality control procedures.
• Liaise directly with Clinical Research Associate (CRA) to ensure data discrepancies are addressed in a timely manner.
• Act as point of contact for project manager, statistician and/or sites, regarding clinical data, data reporting needs and data analysis.
• Contribute to Data Management (DM) documents such as Data Management Plan (DMP), Data Validation Plan, Data Review Plan, annotated CRF, CRF Completion Guidelines to ensure standardization.
• Contribute during database vendor qualification and audit.
• Prepare presentations for colleagues and present clinical data status reports for both internal and external stakeholders.
• Work independently within projects and actively seeks to develop the role further to support Clinical Affairs projects.
• Assist in building departmental initiatives.
• Be responsible for support of multiple studies simultaneously in a dynamic environment.

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