Clinical Trial Manager

The role

You will lead clinical aspects of studies across multiple countries and lead CRAs. You will manage operational delivery including site selection, start-up, enrolment, monitoring, and data cleaning.

What you will do

• Management and operational delivery of clinical elements including site selection, start-up, enrolment management, site engagement, monitoring, data cleaning and close-out
• Successful execution of assigned trials and ensuring 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 relationships with sites for monitoring, regulatory, IP, site payment and site correspondence
• 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, 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 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) 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
• Demonstrates mastery knowledge of ICH-GCP, meaningful 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. Their offering combines clinical trial designs, operational and medical experts, and advanced biomarker and data analytics solutions.