Clinical Data Specialist

Responsibilities:

Independently ensure all study data is validated in accordance with regional and federal clinical study guidelines.

Oversee database design, testing, and optimization.

Create and implement clinical trial methods for collecting and analyzing site- and patient-specific clinical trial data.

Create and maintain SOWs (contracts) and oversee invoicing.

Perform literature searches and conduct outcomes research and economic modeling projects.

Manage PubStrat publication management system and approval process.

Support EOS copy review process including submittals for review and reference annotation process.

Act as department Training Coordinator for Compliance Wire.

Manage approvals for master service agreements, work proposals, and other contracts with Legal and third-party consultants.

Manage Totality HCC approval process.

Responsible for communicating business related issues or opportunities to next management level.

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed.

Requirements:

BA/BS in Biology is highly preferred

Good organizational and math skills

Must be able to prioritize and make quick decisions

Knowledge of data collection practices and Medical Terminology

Knowledge of Good Research Principles

Ability to work under deadlines in a fast-paced work environment

Computer literacy required in Microsoft Office such as Word, Excel and Outlook

Prior knowledge of electrophysiology is preferred, but not required

This position may require work in clinical and/or laboratory environments.