Pfm

Clinical Trial Manager

Remote, Slovakia. Posted a month ago

The role

You will lead clinical aspects of studies across multiple countries and manage CRAs. You will oversee site selection, start-up, enrolment, monitoring, and data cleaning to ensure trial deliverables are met.

What you will do

  • Management and operational delivery of clinical elements including site selection, start-up, enrolment, and monitoring
  • Successful execution of assigned trials and completion of trial deliverables
  • Ensure appropriate communication, regulatory documentation, and ongoing oversight of assigned trials
  • Mentoring and training of team members
  • Identify challenges to study timelines and offer creative action plans
  • Lead CRAs in establishing site relationships and oversight of monitoring, regulatory, IP, and site payment
  • Maintain team focus on study priorities through cross-functional partnerships

Required qualifications

  • Bachelor’s degree or equivalent combination of education/experience in science or health-related field
  • 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 the area of 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 (MS Office, MS Project, PowerPoint)
  • Software experience (CTMS, eTMF, EDC, IXRS)
  • Demonstrated ability to develop positive working relationships with internal and external organizations
  • Core understanding of medical terminology and clinical trial activities
  • Mastery knowledge of ICH-GCP, Precision SOPs, and regulatory guidance

Nice to have

  • Experience with CAR-T and Radiopharmaceuticals

Before you apply

  • Candidates must be legally authorized to work in the country of employment without employer sponsorship

About the company

Precision for Medicine is a precision medicine CRO. The company combines clinical trial designs, operational and medical experts, and advanced biomarker and data analytics solutions.

Clinical Trial Manager at Pfm | JobZoey