Senior Clinical Data Manager

Position Summary:

• Manages all aspects of the clinical trial data management process from study start up to post database lock.
• Oversee and/or perform database development and testing.
• Follows Standard Operating Procedures / Work Instructions (SOPs/WIs); regulatory directives; study specific plans and guidelines.

Essential Functions:

• Provide input and manage timelines to ensure clinical data management deadlines are met.
• Develop CRF specifications from the clinical study protocol and coordinate review/feedback from stakeholders.
• Perform medical coding of medical terms to ensure medical logic and consistency.

Requirements:

• Brings 8+ years’ experience and the ability to handle a variety of clinical research tasks.
• Has broad knowledge of drug, device and/or biologic development and effective data management practices.
• Possesses strong leadership and interpersonal skills.