Clinical Trial Manager

1 month, 2 weeks 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 operational delivery of clinical trial activities, including site selection, start-up, enrolment management, site engagement, monitoring planning and execution, data cleaning, and close-out.
  • Own the successful execution of assigned trials and ensure completion of trial deliverables.
  • Coordinate communication, regulatory documentation, and ongoing oversight of assigned studies with cross-functional team members.
  • Lead CRAs in building site relationships and overseeing monitoring, regulatory, investigational product, site payment, and site correspondence activities.
  • Identify risks, timeline challenges, and deliverable issues, then develop creative action plans for the team and sponsor.
  • Mentor and train team members to support continued growth and study execution.
  • Maintain focus on study priorities through effective cross-functional partnerships and clear communication.
  • Oversee clinical aspects of studies across multiple countries and ensure scope and quality are maintained.
  • Act as a central point of intelligence for studies and provide consultative trial management support.

Requirements

  • Bachelor’s degree, or equivalent combination of education and experience, in a science- or health-related field.
  • Experience in oncology, including clinical trial management experience in oncology.
  • Demonstrable experience leading clinical aspects of studies across multiple countries in a CRO, pharma, or biotech environment in a clinical lead role.
  • 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 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 trials with advanced biomarker and data analytics capabilities.
  • Chance to work on targeted, adaptive clinical trials in a highly specialized CRO environment.
  • Equal opportunity employer status with reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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