Accountable for the end-to-end delivery of site start-up activities across clinical studies, from site identification through site activation.
Work in close collaboration with the Clinical Project Manager (CPM) and/or Clinical Operations Study Lead.
Lead the strategy development and execution of global site identification, feasibility, and selection for new and ongoing oncology trials.
Collaborate with cross-functional stakeholders and external vendors involved in site selection and activation processes.
Oversee the preparation and execution of CDAs, site contracts, and ICFs.

Requirements

Minimum of 8 years of experience in clinical drug development, clinical program management, or equivalent academic experience in clinical trials.
Bachelor’s degree in a related discipline (preferably life sciences) or an equivalent combination of education and experience.
Comprehensive knowledge of ICH-GCP and international clinical trial regulations; working knowledge of GMP/GDP principles.
Thorough understanding of oncology clinical research and operational considerations.
Working knowledge of current global regulatory requirements and guidelines governing clinical trials.

Benefits

merit-based salary increases
short incentive plan participation
eligibility for our 401(k) plan
medical, dental, vision, life and disability insurances
flexible paid time off
11 paid holidays plus additional time off for a shut-down period during the last week of December
80 hours of paid sick time upon hire and each year thereafter

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical drug developmentclinical program managementsite start-up activitiessite identificationsite activationfeasibility assessmentcontract preparationICF preparationCDA executiononcology clinical research

Soft Skills

collaborationleadershipstrategic developmentcommunicationstakeholder management

Certifications

Bachelor’s degree in life sciencesICH-GCP knowledgeGMP knowledgeGDP knowledge