Clinical Trial Manager

5 hours, 26 minutes ago
Full-time
Senior
Project and Program Management
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Manage the clinical and operational delivery of assigned trials, including site selection, start-up, enrolment management, site engagement, monitoring, data cleaning, and close-out.
  • Lead CRAs and oversee study-level clinical oversight across multiple countries.
  • Ensure trial deliverables are completed on time and within scope while maintaining quality.
  • Coordinate communication, regulatory documentation, and ongoing oversight with cross-functional team members.
  • Mentor and train team members supporting the study.
  • Identify risks, challenges, and timeline threats, and develop creative action plans with the team and sponsor.
  • Maintain strong site relationships and oversee monitoring, regulatory, investigational product, site payment, and site correspondence activities.
  • Keep the team aligned on study priorities through effective cross-functional partnership and communication to support client satisfaction.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience in a science or health-related field.
  • Experience in oncology, 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.
  • Ability to communicate effectively in English.
  • Demonstrated computer skills with MS Office, MS Project, and PowerPoint.
  • Experience with CTMS, eTMF, EDC, and IXRS systems.
  • Ability to build positive working relationships with internal and external organizations.
  • Core understanding of medical terminology and clinical trial activities as related to a clinical development plan.
  • Mastery knowledge of ICH-GCP, Precision SOPs, and regulatory guidance, with the ability to implement them.

Benefits

  • Remote work available in the UK, Hungary, Poland, Romania, Serbia, or Slovakia.
  • Opportunity to work on precision medicine and oncology studies with a specialized CRO.
  • Chance to work with advanced biomarker and data analytics solutions and targeted, adaptive clinical trials.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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