Regional Project Lead
Core
Drive successful delivery of clinical trials across multiple countries by managing project planning, site selection, monitoring, and regulatory submissions.
Role type
Senior Clinical Project Lead (Oncology/Gastroenterology)
Builds
Clinical studies for pharmaceutical sponsors
Domain
Clinical Research / Life Sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical Trial Management, Independent On-site Monitoring, Therapeutic Area Expertise (Oncology/Gastroenterology), Project Planning, KPI Management, Contract Negotiation, Regulatory Submissions, Team Supervision, Data Retrieval & Query Resolution
Preferred skills
Study Manager experience, Training delivery, Audit preparation
Technologies
MS Office, MS Project
Responsibilities
Ensure compliance with ICH-GCP and industry regulations; Manage project timelines and subject enrollment targets; Coordinate site contractual startup and budget negotiations; Supervise clinical project team members and conduct therapeutic area training; Oversee investigator payments and CRF data retrieval; Prepare regulatory and Ethics Committee submissions; Supervise monitoring visits and audit preparations.
Seniority
Senior, hands-on IC with leadership responsibilities
