Global DCT & Clinical Trials Project Lead

ProPharma; United States; Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

ProPharma in the United States is seeking a seasoned clinical research professional to oversee decentralized clinical trial (DCT) study activities from startup to closeout. You will lead study teams, ensure adherence to ICH/GCP, and manage vendor relations to deliver on time, within budget, and with high quality.

This role emphasizes collaboration across Sponsor, CRO, and internal sites, with a hybrid work model and opportunities to mentor GCPCs, GCCMs, and GCPCs while upholding ProPharma's SOPs

Qualifications

• Current knowledge of ICH/GCP and applicable regulations.
• Proven ability to independently execute studies from startup to closeout.
• Strong SOPs, global regulations, and outsourcing know-how.

Responsibilities

• DCT study oversight and management.
• Prioritize tasks per study plan and SOPs to ensure on-time delivery.
• Main escalation point for site, sponsor, vendors, and GCPC/GCCM.
• Create study documents and training; submit for sponsor approval.
• Oversee site setup including DCV introduction and training.
• Develop protocol-specific training and amendments for GCCs and GCPCs.
• Manage vendors (central pharmacy/lab/equipment) for each study.
• Lead Sponsor/CRO, Central Lab and Vendor teleconferences.
• Track objectives and KPIs for Decentralized Visits.
• Handle monthly unit trackers, invoices, and GCC payments.
• Provide guidance to GCPCs and GCCs; ensure quality management.
• Escalate risks and mitigation plans to leadership; manage study closeout.

Skills

ICH/GCP regulations

Independent study execution

SOPs & Global Regulations

Multi-tasking & organization

Leadership & mentoring

Professional communication

Education

Bachelor's Degree or equivalent experience

Job description

ProPharma in the United States is seeking a seasoned clinical research professional to oversee decentralized clinical trial (DCT) study activities from startup to closeout. You will lead study teams, ensure adherence to ICH/GCP, and manage vendor relations to deliver on time, within budget, and with high quality.

This role emphasizes collaboration across Sponsor, CRO, and internal sites, with a hybrid work model and opportunities to mentor GCPCs, GCCMs, and GCPCs while upholding ProPharma's SOPs