Clinical Data Manager II

Job Description

Precision Medicine Group is seeking a Clinical Data Manager II to manage all aspects of the clinical trial data management process. The Clinical Data Manager II will be responsible for projects from study start-up to post-database lock, under some supervision, while adhering to SOPs/WIs, regulatory directives, and study-specific guidelines. This role involves overseeing and/or performing database development and testing.Responsibilities include:

• Serving as the primary DM contact for assigned clinical projects.
• Developing CRF specifications from the clinical study protocol.
• Conducting database build UAT and maintaining quality-controlled documentation.
• Specifying requirements for all edit check types.
• Overseeing the completeness of data management documentation for the Trial Master File.
• Reviewing and querying clinical trial data according to the Data Management Plan.
• Performing medical coding of medical terms.
• Liaising with third-party vendors.

Requirements:

• 5+ years’ Clinical Data Management experience.
• Proficiency in Microsoft Office.
• Excellent organizational and communication skills.
• Fluency in English.
• Experience in utilizing a clinical database management system.
• Broad knowledge of drug, device, and/or biologic development.

Precision Medicine Group offers:

• Opportunity to work on a variety of clinical research tasks.
• A role in developing and maintaining Standard Operating Procedures (SOPs).
• Exposure to strategy meetings and client engagement.