Clinical Trial Manager

🔥 7 minutes ago

🌐 Romania, Hungary, +3 more countries – Remote

🇷🇴 Romania – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Manage and operationally deliver clinical elements of trials, including site selection, start-up, enrollment management, site engagement and support, monitoring planning and execution, data cleaning, and close-out • Execute assigned trials successfully and ensure completion of trial deliverables • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials in collaboration with cross-functional team members • Mentor and train team members • Identify challenges to study timelines and deliverables and propose creative action plans to the team and sponsor • Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities • Maintain focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction • Serve as the central intelligence hub for managed studies and lead CRAs across multiple countries

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in oncology • Demonstrable experience leading clinical aspects of studies across multiple countries in a CRO, Pharma, or Biotech company in a dedicated clinical lead role • Significant clinical trial management experience in oncology • Working knowledge of GCP/ICH guidelines and the clinical development process • Availability for domestic and international travel, including overnight stays • Must communicate effectively in English • Demonstrated computer skills with MS Office, MS Project, and PowerPoint • Software experience with CTMS, eTMF, EDC, and IXRS • Ability to develop positive working relationships with internal and external organizations • Core understanding of medical terminology and clinical trial activities related to clinical development plan execution • Mastery of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with ability to implement them • Must be legally authorized to work in the country of employment without employer sponsorship