Clinical Data Manager

The Fountain Group is currently seeking a Clinical Data Manager for a prominent client of ours. This position is located in Sylmar, CA. Details for the position are as follows:

**100% ONSITE: Must be located within 1 hour of the site**

Job Description:

Overview:

• This position for a Clinical Data Manager will oversee 3-5 clinical trials from data management perspective, and together with assigned Coordinator, takes care of all related activities from CRF design, clinical data review and oversight, to trial closure related data activities.
• The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.
• As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.

Main Responsibilities:

• Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.
• Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
• Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.
• Conduct Central Monitoring activities, as described in Central Monitoring Plan.
• Direct all data cleaning activity related to assigned studies.

Qualifications:

• MUST BE LOCATED 1HR OR LESS FROM THE SITE
• BS/MS in life science, computational science, or mathematics
• 3+ years clinical operations
• Strong clinical data management
• Relevant Skills: CRF Design | Clinica Data Review | Clinical Data Oversight | Trial Closure Data | Data Management / Analysis (NOT stats analysis) | Data Collection for Clinical Trials

Compensation: $30-46 per hour depending on experience