Clinical Trials Program Manager — Remote/Hybrid

PPG US ProPharma Group, LLC

Town of Deerfield (WI)

Hybrid

USD 90,000 - 130,000

Full time

3 days ago
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Benefits offered by this job

Hybrid work model

Job summary

ProPharma Group seeks a seasoned Clinical Research Operations professional to oversee study plans, escalate issues, and manage vendor relationships across diverse therapeutic areas. You will develop training, coordinate site setups, and ensure adherence to ICH/GCP and SOPs.

The role emphasizes leadership of multidisciplinary teams, mentoring junior staff, and maintaining regulatory compliance throughout the study lifecycle.

Qualifications

  • Current knowledge of ICH/GCP and applicable regulations.
  • Proven track record of independent execution of successful studies from startup to closeout.
  • Competent in standard business procedures (SOPs, Global Regulations, OEC, Outsourcing).
  • Well organized and able to multi-task.
  • Positive and energetic attitude towards leadership of study teams.
  • Professional, well spoken, and articulate.
  • Experience mentoring, oversight, issue escalation and resolution.

Responsibilities

  • Ensures timely operationalization of each project plan per SOPs and regulatory guidelines.
  • Serves as main point of contact for issue escalation (Site, Sponsor, Vendors, GCPC, GCCM).
  • Creates study-specific documents and training; submits to Sponsor for approval.
  • Oversees site setup including DCV introduction and training.
  • Develops protocol-specific training for GCCs and GCPCs.
  • Manages study team communications and risk mitigation.
  • Ensures compliance with Quality Management System and SOPs.

Skills

ICH/GCP knowledge
Independent study execution
SOPs & Regulations
Multi-tasking
Leadership
Communication
Team management

Education

Bachelor’s degree

Job description

ProPharma Group seeks a seasoned Clinical Research Operations professional to oversee study plans, escalate issues, and manage vendor relationships across diverse therapeutic areas. You will develop training, coordinate site setups, and ensure adherence to ICH/GCP and SOPs.

The role emphasizes leadership of multidisciplinary teams, mentoring junior staff, and maintaining regulatory compliance throughout the study lifecycle.

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