Senior Clinical Data Manager (Contractor) (Office or Remote)

Overview

The Senior Clinical Data Manager provides clinical data expertise to project teams in an outsourced and/or insourced Clinical Data Management model. The successful candidate will have advanced knowledge of end-to-end clinical research lifecycle and Clinical Data Management processes, as well as global regulatory, and industry rules and guidance (i.e. ICH, GCP) to support drug or biologics development.

In Short

• Support all Data Management activities for assigned projects.
• Act as Lead Data Manager or Support Data Manager on studies.
• Participate on cross functional teams as the Data Management expert.
• Lead Data Management start-up activities.
• Ensure data meets analysis requirements.
• Participate in data cleaning and review.
• Review and contribute to study documents.
• Maintain Data Management documentation.
• Collaborate for data transfers and analytics.
• Develop and revise SOPs and templates.

Requirements

• Bachelor's Degree with at least 4 years’ experience in Clinical Data Management.
• Excellent verbal and written communication skills.
• Highly organized, collaborative, and detail-oriented.
• Ability to prioritize and adapt in a fast-paced environment.
• Experience with EDC systems, preferably Medidata.
• Advanced knowledge of data collection and cleaning best practices.
• Understanding of vendor management and data transfer workflows.
• Knowledge of ICH, FDA, and GCP regulations.
• No travel required.

Benefits

• Equal Opportunity Employer.