Clinical Trial Manager

6 days ago

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $35.2M Venture Round on 2021-03

Description

• Opportunity for an experienced Clinical Trial Manager to join our growing team. • Conduct clinical trial management across multiple countries, ensuring quality delivery. • Manage operational delivery of clinical elements within a trial including site selection, start-up, enrolment management, monitoring planning and execution, and close-out. • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials by collaborating with other team members. • Mentor and train team members to achieve successful outcomes.

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 your studies across multiple countries in a CRO / Pharma or Biotech company (in a dedicated 'clinical lead' role). • 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 (MS Office, MS Project, PowerPoint) and software experience (CTMS, eTMF, EDC, IXRS). • Demonstrated ability to develop positive working relationships with internal and external organizations. • Demonstrates core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan. • Demonstrates mastery knowledge of ICH-GCP, meaningful Precision SOPs, and regulatory guidance, as well as the ability to implement.