Manager, Global Clinical Monitoring

🕒 August 10

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

👻 Ghost score 21%

infoinfo

🗣️🇵🇱 Polish Required

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Logo of Precision Medicine Group

Precision Medicine Group

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Provide line management to CRAs, IHCRAs and CTMs across assigned European countries, driving performance, engagement, accountability and career growth • Generate action plans and provide strategic oversight to optimize clinical operations performance and quality delivery • Partner with Clinical Operations leadership and project teams on resource allocation, utilization and deployment across projects and countries • Perform accompanied site visits to assess CRA competencies, identify development opportunities and provide coaching • Identify quality risks, performance concerns and operational challenges, implementing corrective and preventive actions • Ensure staff have required resources, training, tools, systems access and support • Monitor workforce performance metrics and trends to support decision-making, workforce planning and operational excellence • Ensure timely completion of administrative, compliance and training activities • Lead or participate in departmental, regional and global process improvement, standardization, digital enablement and workforce development initiatives • Develop and drive solutions that enhance quality, efficiency, employee experience and business performance • Participate in recruitment, selection, onboarding and integration of CRAs, IHCRAs and CTMs • Foster collaboration, continuous learning, accountability and high performance • Represent Precision for Medicine professionally to internal stakeholders, clients and external partners • Perform other duties and special projects assigned by leadership • Contribute to the development and execution of targeted, adaptive clinical trials that use biomarkers and molecular-level insights to optimize oncology development pathways

🎯 Requirements

• Degree or equivalent experience, ideally in a scientific, life sciences or healthcare discipline • Fluency in English and Polish • Strong clinical operations experience within a CRO, biotechnology or pharmaceutical environment, including prior onsite monitoring experience • Demonstrated direct line management experience leading CRAs and/or other clinical operations professionals • Demonstrated experience coaching, developing and managing employee performance • Strong knowledge of ICH-GCP, applicable regulatory requirements and clinical trial conduct • Ability to work independently, solve problems proactively and drive successful outcomes • Willingness and ability to travel domestically and internationally, including overnight travel, up to approximately 25% • Proficiency with clinical research systems and technology, including EDC, EMR and other clinical trial management tools • Preferred: experience managing CRAs, IHCRAs and/or CTMs across multiple countries or regions • Preferred: oncology clinical research experience • Preferred: experience supporting process improvement, operational excellence or organizational change initiatives • Preferred: experience in resource planning and workforce management within a matrix environment • Preferred: track record of leading cross-functional or departmental initiatives beyond core line management responsibilities • Strong people leadership, coaching, emotional intelligence and team-development capability • Excellent organizational, prioritization and problem-solving skills • Strong understanding of clinical trial operations and site, study and operational challenges • Effective collaboration and influencing skills • Excellent verbal, written, presentation and stakeholder communication skills • Commitment to continuous improvement, quality, accountability and operational excellence • Professionalism, integrity and work ethic aligned with company values • Please apply in English

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