Clinical Data Specialist - Urgent Hire

• 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.