Clinical DCT Project Manager - Remote/Hybrid

ProPharma

Raleigh (NC)

Hybrid

USD 100,000 - 140,000

Full time

33 hours ago
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Job summary

ProPharma is seeking a DCT Study Oversight Specialist to guide decentralized trials across sponsors and sites, ensuring ICH/GCP compliance and timely delivery.

You will coordinate with CROs, labs, and vendors, maintain study documentation, and lead training activities to promote quality and efficiency. This role emphasizes leadership and cross-functional collaboration in a hybrid work setting near Raleigh, NC.

Qualifications

  • Current knowledge of ICH/GCP and applicable regulations.
  • Proven track record of independent execution of studies from startup to closeout.
  • Well organized and able to multi-task.

Responsibilities

  • Oversee DCT study oversight and management.
  • Set priorities for each study team member in accordance with SOPs, ICH/GCP and regulatory guidelines.
  • Main point of contact for issue escalation (Site, Sponsor, Vendors, GCPCs and GCCMs).
  • Create study-specific documents and training and submit to Sponsor for approval.
  • Oversee site setup including DCV introduction and training.
  • Develop and deliver protocol-specific training to GCCs, GCCMs, and GCPCs.
  • Lead vendor management and teleconferences with Sponsor/CRO, Central Lab and Vendors.
  • Track objectives and KPIs related to Decentralized Visits.
  • Manage monthly unit trackers, invoices, and GCC payments.
  • Provide guidance to GCPCs and GCCs assigned to projects.
  • Comply with QMS and SOPs; escalate risks with mitigation plans.
  • Communicate to study teams and manage study closeout.

Skills

ICH/GCP knowledge
Study execution
SOPs & global regulations
Multi-tasking
Leadership & mentoring
Communication & articulation
Study team management & issue handling

Education

Bachelor's Degree or equivalent

Job description

ProPharma is seeking a DCT Study Oversight Specialist to guide decentralized trials across sponsors and sites, ensuring ICH/GCP compliance and timely delivery.

You will coordinate with CROs, labs, and vendors, maintain study documentation, and lead training activities to promote quality and efficiency. This role emphasizes leadership and cross-functional collaboration in a hybrid work setting near Raleigh, NC.

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