Clinical Trial Manager

🔥 44 minutes ago

🌐 Romania, Hungary, +3 more countries – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 21%

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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

• Manage and operationally deliver clinical elements of 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 propose creative action plans to the team and sponsor • Lead CRAs in site relationships and oversight of monitoring, regulatory, IP, site payment, and site correspondence activities • Maintain focus on study priorities through cross-functional partnerships and communication to achieve client satisfaction

🎯 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 • Must be able to communicate effectively in the English language • Demonstrated 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, with ability to implement • Must be legally authorized to work in the country of employment without employer sponsorship

🏖️ Benefits

• Remote work arrangement • Regular full-time employment • Continued professional growth support • Mentoring and training opportunities • Domestic and international travel opportunities

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