[Hiring] Central Monitoring Specialist @Fortrea

Role Description

The Central Monitoring Specialist is responsible for the execution of key Central monitoring activities and assisting in several key activities. The role includes:

• Collaborating with the study team to execute Central Monitoring and comply with applicable plans.
• Conducting reviews of the applicable Informatics platform and communicating findings at the country, study, site, and subject levels.
• Conducting central monitoring activities in a timely manner and reporting, recommending changes in risk profile, and escalation as appropriate.
• Conducting risk assessments, reviewing risk indicators, and recommending mitigations to project teams.
• Identifying site and subject level risk in non-contributing RI that may affect the study level risk.

Summary of Responsibilities:

• Performing Central monitoring activities for more than 3 studies and multiple customer portfolios.
• Acting as backup for the leads in Central Monitoring activities.
• Creating, reviewing, and comparing monthly status reports of study-specific important risk indicators from data sources.
• Organizing Study Risk Assessment meetings.
• Following up with outstanding site findings, query resolution, and administrative issues.
• Supporting in populating the required tools with the baseline site risk profile.
• Supporting the development of informatics Platform requirements, including design of visualizations.
• Writing scripts for User Acceptance Testing and performing UAT for study-specific and new platforms and tools.
• Drafting the Configuration Plan and other applicable Plans in collaboration with the study team.
• Populating the tools, testing variable risk factors, and adjusting trigger levels and study-specific risk factors.
• Performing ongoing reviews, preparing and recommending mitigation actions, and ensuring identified issues are followed to resolution.
• Uploading monthly risk review reports in the e-TMF or Veeva vault or central repository as necessary.

Qualifications

• University / college degree (life science preferred) from an appropriately accredited institution.
• Relevant and equivalent experience may be considered in lieu of educational requirements.
• Good ability to work with peers.
• Good analytical skills, strong detail focus, and accuracy.
• Good planning, time management, and organizational skills.
• Some influencing, negotiation, and problem-solving skills.
• Some project and risk management skills.

Requirements

• Minimum of 3-5 years of relevant clinical research experience in a pharmaceutical company/CRO or equivalent experience.
• Experience with increasing levels of responsibility in clinical trial-related roles (e.g., project management, clinical monitoring, data management, and informatics).

Preferred Qualifications Include

• Post-graduation in Life sciences or any other applicable qualification and experience.