Clinical Trial Manager

7 hours, 2 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 planning and execution, data cleaning, and close-out.
  • Serve as the central point of coordination for study activities across multiple countries and ensure adherence to timelines, scope, and quality standards.
  • Oversee trial deliverables and drive successful execution of assigned studies.
  • Coordinate communication, regulatory documentation, and ongoing oversight of assigned trials with cross-functional team members.
  • Lead CRAs in building site relationships and supporting monitoring, regulatory, IP, site payment, and site correspondence activities.
  • Mentor and train team members to support continued growth and effective trial delivery.
  • Identify risks, timeline threats, and delivery challenges, and develop creative action plans for the team and sponsor.
  • Maintain team focus on study priorities through effective cross-functional partnership and communication to maximize client satisfaction.

Requirements

  • Bachelor’s degree or equivalent combination of education and experience in a science or health-related field, including oncology experience.
  • Demonstrable experience leading the clinical aspects of studies across multiple countries in a CRO, pharmaceutical, 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 develop positive working relationships with internal and external organizations.
  • Strong understanding of medical terminology and clinical trial activities related to clinical development planning.
  • Mastery 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 trials with a specialized CRO.
  • Collaborative environment with cross-functional experts and CRA leadership responsibilities.
  • Chance to support novel, targeted, and adaptive clinical trial development.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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