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 from study start-up to post-database lock. The Clinical Data Manager II will adhere to SOPs/WIs, regulatory directives, and study-specific plans and guidelines. This role involves overseeing and/or performing database development and testing.She will be the primary Data Management (DM) contact and/or contributor for assigned clinical projects, ensuring responsiveness and timely task completion. She may also support another Lead DM as a backup or team member. Role involves:

• Developing CRF specifications from the clinical study protocol.
• Conducting database build UAT and maintaining quality-controlled database build documentation.
• Specifying requirements for all edit check types.
• Overseeing 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.
• Coordinating SAE/AE reconciliation.
• Liaising with third-party vendors.

Requirements:

• Bachelor's degree and/or related experience.
• 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.
• Ability to undertake occasional travel.

Role offers:

• Opportunity to work with a leading clinical research organization.
• Chance to contribute to important clinical trials.
• Collaborative and supportive work environment.