Senior Central Monitor

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

📋 Description

• Conduct remote site monitoring and management activities for designated projects.

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

• Aid in the collection of data and preparation of reports related to recruitment plans, enrollment, drug supply status, site payment status, and other clinical trial tracking activities.

• Support data risk assessments as assigned.

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

• Facilitate document collection, visit preparation, study data review, and central monitoring tasks as assigned.

• Adhere to Standard Operating Procedures, regulatory requirements, ICH and GCP guidelines, and study-specific plans.

• Perform additional duties as assigned.

⛳️ Requirements

• Strong communication and interpersonal skills with the ability to collaborate with cross-functional internal and external stakeholders.

• Capability to prioritize multiple tasks, plan proactively, and achieve goals utilizing clear instructions and procedures.

• Ability to contribute to the development of tools and processes that enhance measured project efficiencies.

• Proficiency in clinical trial execution systems, such as Electronic Document Management Systems, Electronic Data Capture Systems, and Clinical Trial Management Systems.

• Solid understanding of general quality assurance concepts and practices.

• Highly organized with a keen attention to detail.

• Bachelor’s degree is preferred.

• Candidates without a formal degree may be considered if they possess comparable depth and breadth of training and experience that meet job-specific criteria.

• A minimum of 3 years of experience in study coordination and in-house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or within a regulated environment.

• Working knowledge of CluePoints RBQM System is desired.

• Experience in long-haul COVID/Pulmonary is preferred.

• Compliance with FDA and/or local regulations, ICH GCPs, ProPharma Group SOPs, and project plans is essential.

🏝️ Benefits

• Support for remote working arrangements.

• Encouragement of hybrid working for new hires within a reasonable commuting distance of an office, as agreed with the manager.

• Commitment to an Equal Opportunity Employer workplace.

• Dedication to diversity, equity, and inclusion.

• A safe and empowering workplace environment.