Clinical Trial Manager

🔥 46 minutes ago

🌐 United Kingdom, Hungary, +5 more countries – Remote

🇬🇧 United Kingdom – Remote 🇭🇺 Hungary – Remote 🇵🇱 Poland – Remote 🇷🇴 Romania – Remote 🇷🇸 Serbia – Remote 🇸🇰 Slovakia – Remote 🇪🇸 Spain – 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 through close collaboration with functional team members • Mentor and train team members • Identify challenges to study timelines and deliverables and propose creative action plans to the team or sponsor • Lead CRAs in establishing site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities • Maintain team focus on study priorities through cross-functional partnerships and effective communication to achieve client satisfaction • Serve as the central intelligence hub for managed studies • Lead CRAs and oversee clinical aspects of studies across multiple countries while ensuring timeline adherence, scope, and quality delivery

🎯 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 • Experience with CAR-T and Radiopharmaceuticals would be a strong plus • Working knowledge of GCP/ICH guidelines and the clinical development process • Availability for domestic and international travel, including overnight stays • Must be able to communicate effectively in the English language • Demonstrated computer skills in MS Office, MS Project, and PowerPoint • Software experience with CTMS, eTMF, EDC, and IXRS • Demonstrated ability to develop positive working relationships with internal and external organizations • Core understanding of medical terminology and clinical trial activities related to execution of a clinical development plan • Mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, with ability to implement • Candidates must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Remote work • Opportunity for continued professional growth and development • Mentoring and training of team members • Domestic and international travel opportunities • Equal opportunity employment • Reasonable accommodation available for applicants with disabilities

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