Temp Manager, Monitoring Oversight

Pay Range: $55 - $75/hr

Remote Role (US Only)

12 Month Contract

The Temp, Manager, Monitoring Oversight is accountable for centralized monitoring activities for global and/or complex trials, analytical data review of key risk and/or operational performance data and presenting as an integral member of the Clinical Study team for clinical development studies. The reviews include interpretation of Key Risk Indicator (KRI) and/or Key Performance Indicator (KPI) data housed in an analytical tool as well as a comprehensive review of supplemental operational data/trends and issues to be interpreted, reported and presented to the study teams. The Manager, Monitoring Oversight will be responsible for supporting a number of studies within a therapy area and program-level. They will work closely with other Central Monitors to ensure effective identification, conduct and reporting of central monitoring activities in support of sponsor oversight obligations. The role will contribute to continued process improvement and innovation activities, and industry collaborations in central monitoring capabilities.

A typical day may include the following:

• Responsible for development and authoring activities of the Central Monitoring Plan
• Participate in the Study Quality Risk Assessment and Control Tracker (QRACT) development
• Present at CRO kick-off meeting
• Work with data analysts in the technical configurations, implementation, and execution of Central Monitoring RBQM system across studies.
• Conduct & Communicate Study-level Central Monitoring Review for assigned studies in a given program/therapeutic area using data analysis tools

The role may be for you if:

• Problem solving abilities, troubleshooting and resourcefulness
• Analytical problem-solving experience
• Working knowledge of clinical drug development process as well as ICH, GCP guidelines, and regulations
• Effective communication and interpersonal skills; ability to build relationships internally and externally
• Understands current and possible future business trends and information

To be considered for this role, you must have 7+ years of relevant experience in the life science industry (Pharma, Biotech, MedDevice) and a bachelor's degree. We also expect you to have central monitoring experience.

This is a contract position at Regeneron with Magnit Global being the Employer.

To do our best work we need different viewpoints.  Therefore, we celebrate diversity and embrace inclusion. As an equal opportunity employer, we are dedicated to building a team that represents a variety of backgrounds, perspectives, and skills.  We strive to ensure that we maintain a positive and enriching work environment for all.

W2 only, no third party solicitation