Clinical Trials Project Manager (Remote/Hybrid)

ProPharma Group

United States

Hybrid

USD 110,000 - 150,000

Full time

3 days ago
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Job summary

ProPharma Group seeks an experienced clinical research professional to oversee decentralized clinical trials (DCT) studies in the United States. You will manage study plans, set priorities, and ensure adherence to ICH/GCP and regulatory guidelines.

As the main point of contact for sponsor, vendors, and study teams, you will develop protocol-specific training, coordinate site setup, track KPIs, and manage monthly trackers and payments. A hybrid work arrangement is supported.

Qualifications

  • Bachelor’s Degree or equivalent experience required.
  • Minimum of 2 years direct clinical research experience.
  • Knowledge of ICH/GCP guidelines and regulatory requirements.

Responsibilities

  • DCT study oversight and management.
  • Ensures timely operationalization of each project plan according to SOPs and regulatory guidelines.
  • Main point of contact for issue escalation (Site, Sponsor, Vendors, GCPCs, GCCMs).
  • Creates study-specific documents and training for Sponsor approval.
  • Oversees site setup including DCV introduction and training.
  • Develops protocol-specific training for GCCs and GCPCs.
  • Sets up and coordinates vendors (central lab, central pharmacy, equipment).
  • Leads Sponsor/CRO, Central Lab and Vendor teleconferences.
  • Tracks objectives and KPIs for Decentralized Visits.
  • Manages monthly unit trackers, invoices, and GCC payments.
  • Provides guidance to GCPCs and GCCs; escalates risks with mitigation plans.
  • Communicates with study teams and manages study closeout.

Skills

ICH/GCP knowledge
Project management
Regulatory compliance
Budget management
Communication skills

Education

Bachelor’s Degree or equivalent experience

Job description

ProPharma Group seeks an experienced clinical research professional to oversee decentralized clinical trials (DCT) studies in the United States. You will manage study plans, set priorities, and ensure adherence to ICH/GCP and regulatory guidelines.

As the main point of contact for sponsor, vendors, and study teams, you will develop protocol-specific training, coordinate site setup, track KPIs, and manage monthly trackers and payments. A hybrid work arrangement is supported.

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