Senior Central Monitor

🕒 September 16

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🦅 H1B Visa Sponsor

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👻 Ghost score 12%

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Logo of ProPharma

ProPharma

5001 - 10000 employees

Founded 2001

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

💰 $8.6M Venture Round on 2020-10

Healthcare • Logistics • Manufacturing

ProPharma is a leading research consulting organization in the life sciences industry. The company specializes in providing custom solutions across the full product lifecycle, from early discovery to post-market monitoring. ProPharma's services include regulatory sciences, clinical research solutions, quality and compliance services, pharmacovigilance, medical information, and R&D technology. Known for its deep domain expertise, ProPharma assists clients in the pharmaceuticals, biotechnology, and medical device sectors with regulatory support, clinical development, and quality management. ProPharma's global team supports a wide range of therapeutic areas including oncology, cardiovascular, and rare diseases, among others, ensuring effective and efficient delivery of life-saving therapies.

📋 Description

• Perform remote site monitoring and management activities for assigned projects in accordance with FDA and/or local regulations, ICH GCPs, ProPharma Group SOPs, and project plans • Support study monitoring teams in implementing study strategies, initiatives, processes, and standards • Support collection of data and report generation for recruitment planning, enrollment, drug supply status, site payment status, and other clinical trial tracking • Support data risk assessments as assigned • Support monitoring teams throughout the study, including communication with clinical site institutions as appropriate • Support document collection, visit preparation, study data review, and central monitoring activities as assigned • Develop or contribute to tools and processes that improve project efficiency • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree preferred; persons without a formal degree who have comparable depth and breadth of training and experience and meet job-specific criteria are eligible for consideration • Minimum 3 years of experience in study coordination and in-house monitoring, or relevant work experience in the Biotechnology or Pharmaceutical industries or a relevant regulated environment • Effective communication and interpersonal skills • Ability to partner with cross-functional internal and external stakeholders • Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures • Ability to contribute to development of tools and processes that increase measured project efficiencies • Proficiency with clinical trial execution systems, including Electronic Document Management Systems, Electronic Data Capture Systems, and Clinical Trial Management Systems • Good understanding of general quality assurance concepts and practices • Highly organized with strong attention to detail • Working knowledge of Cluepoints RBQM System desired • Long-haul COVID/Pulmonary experience desired

🏖️ Benefits

• Remote working support • Hybrid working encouraged for new hires living within a reasonably short commute of a ProPharma office, as agreed with the manager • Equal Opportunity Employer workplace committed to diversity, equity, and inclusion

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