Senior Central Monitor

This is a fully remote position, open to applicants in United States.

📋 Description

• Conduct remote site monitoring and management tasks for designated projects, adhering to FDA and/or local regulations, ICH GCPs, ProPharma Group SOPs, and project plans.

• Assist study monitoring teams in executing study strategies, initiatives, processes, and standards.

• Aid in data collection and the generation of reports for recruitment planning, enrollment status, drug supply status, site payment status, and other clinical trial tracking activities.

• Contribute to data risk assessments as needed.

• Support monitoring teams throughout the study, including appropriate communication with clinical site institutions.

• Facilitate document collection, visit preparation, study data review, and central monitoring activities as required.

• Develop or assist in creating tools and processes that enhance project efficiency.

• Perform additional responsibilities as assigned.

⛳️ Requirements

• A Bachelor’s degree is preferred; candidates without a formal degree who possess equivalent training and experience and meet job-specific criteria will be considered.

• At least 3 years of experience in study coordination and in-house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical sectors, or in a relevant regulated environment.

• Strong communication and interpersonal skills.

• Ability to collaborate with cross-functional internal and external stakeholders.

• Capacity to prioritize multiple tasks, proactively plan, and achieve goals using clearly defined instructions and procedures.

• Ability to contribute to the development of tools and processes aimed at increasing project efficiencies.

• Proficient with clinical trial execution systems, including Electronic Document Management Systems, Electronic Data Capture Systems, and Clinical Trial Management Systems.

• A solid understanding of general quality assurance concepts and practices.

• Highly organized with a keen attention to detail.

• Familiarity with Cluepoints RBQM System is preferred.

• Experience with long-haul COVID/Pulmonary conditions is desirable.

🏝️ Benefits

• Support for remote working.

• Hybrid working is encouraged for new hires residing within a reasonable commuting distance of a ProPharma office, as agreed with their manager.

• A workplace committed to being an Equal Opportunity Employer, with a focus on diversity, equity, and inclusion.