Clinical Trial Manager

🔥 9 minutes ago

🌐 Spain, Hungary, +5 more countries – Remote

🇪🇸 Spain – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote 🇬🇧 United Kingdom – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 21%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

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

• Manage and operationally deliver clinical elements within trials, including site selection, start-up, enrolment 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 functional team members • Mentor and train team members • Identify challenges to study timelines and deliverables and develop creative action plans for the team or sponsor • Lead CRAs in site relationships and oversight of monitoring, regulatory, investigational product, site payment, and site correspondence activities • Maintain study priorities through cross-functional partnerships and communication to achieve client satisfaction • Serve as the central intelligence hub for managed studies and oversee clinical aspects across multiple countries

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field, including experience in the field of 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 • Effective communication in English • Computer skills with MS Office, MS Project, and PowerPoint • Software experience with CTMS, eTMF, EDC, and IXRS • Understanding of medical terminology and clinical trial activities related to clinical development plan execution • Mastery of ICH-GCP, Precision SOPs, and regulatory guidance • Experience with CAR-T and radiopharmaceuticals would be a strong plus

🏖️ Benefits

• Remote work from Hungary, Poland, Romania, Serbia, Slovakia, the UK, or Spain • Regular full-time employment • Domestic and international travel opportunities • Mentoring and training support • Equal opportunity employment • Reasonable accommodation support for applicants with disabilities

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