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Precision Medicine GroupPosted 1 month ago

Senior Project Manager

$147,300–$220,900 year

Remote

Full TimeSenior LevelMediumHealthcare

Job Summary

Manage clinical study projects by serving as the primary point-of-contact to the client, coordinating external vendors, and overseeing the study budget to ensure quality, scope, cost, and time objectives are met. Develop comprehensive project plans with timelines and proactive risk mitigation while maintaining integrated collaboration with clinical operations and functional teams. Ensure quality management including eTMF inspection readiness and implement corrective actions for findings. Prepare status updates and reports for clients and senior management, lead internal and client meetings, and conduct formal presentations such as Bid Defenses. Communicate protocol issues and deviations to Precision management, implement necessary actions, and support business development activities including travel to defense meetings.

Required Qualifications

  • Bachelor's degree or equivalent combination of education/experience in science or health-related field
  • Advanced degree
  • Minimum of 7 years of clinical research experience
  • Minimum of 4 years of direct project management experience
  • Experience in managing complex and global trials
  • Ability to travel domestically and internationally including overnight stays
  • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
  • Experience with Microsoft Project
  • Experience with eTMF
  • Experience with EDC
  • Experience with CTMS
  • Proven communication and interpersonal skills
  • Proven organizational skills
  • Attention to detail
  • Customer service demeanor
  • Knowledge of ICH-GCP
  • Knowledge of relevant Precision SOPs
  • Ability to implement ICH-GCP and Precision SOPs
  • Direct work experience in a global, cross-functional project management environment
  • Good understanding of cross-functional management
  • Good understanding of project planning
  • Good understanding of risk management
  • Good understanding of change management
  • Awareness of appropriate escalation
  • Proven experience in strategic planning
  • Proven experience in risk management
  • Proven experience in change management
  • High level of integrity
  • Ability to lead and inspire excellence within a study team
  • Ability to create an environment where study team members have a sense of ownership
  • Results oriented
  • Accountable
  • Motivated
  • Flexible
  • Proven time management
  • Proven negotiation
  • Proven critical thinking
  • Proven decision making
  • Proven analytical skills
  • Proven interpersonal skills
  • Proven presentation skills
  • Proven verbal communications skills
  • Proven written communications skills
  • Good understanding of project management software
  • In depth proven experience in pharmaceutical research
  • In depth proven experience in device research

Desired Qualifications

  • Advanced degree
  • Experience with oncology
  • Experience with cell and therapy
  • Experience with gene therapy

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