Senior Clinical Project Manager

5 days, 20 hours ago
Full-time
Senior
Project and Program Management
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012

Description

  • Serve as the primary point of contact and escalation point for clients.
  • Coordinate and oversee functional services and external vendors against study timelines and budgets.
  • Manage study scope, identify out-of-scope activities early, and ensure appropriate handling.
  • Oversee the financial health of assigned studies, including profitability, billable hours, billing, and forecasting.
  • Develop comprehensive project plans, timelines, and risk mitigation strategies for trial execution.
  • Ensure project quality management, including eTMF inspection readiness and CAPA implementation.
  • Collaborate with functional operations and review study documentation as needed.
  • Establish tracking metrics to monitor trial and team progress toward project goals.
  • Prepare status updates and report progress, KPIs, solutions, and opportunities to clients and senior management.
  • Lead internal and client meetings, set expectations for the project team, and communicate study issues and deviations with follow-up actions.

Requirements

  • Degree or equivalent combination of education and experience in a science or health-related field; advanced degree preferred.
  • 3-7 years of clinical research experience or proven competencies for the role.
  • 2-4 years of experience leading a project.
  • Experience managing regional trials of moderate complexity and/or supporting complex global trials.
  • Experience with Microsoft Office products, Microsoft Project, eTMF, EDC, and CTMS.
  • Good communication and interpersonal skills for team-based collaboration.
  • Strong organizational skills, attention to detail, and a customer service demeanor.
  • Knowledge of ICH-GCP and relevant Precision SOPs, with ability to implement them.
  • Experience with project management techniques, tools, and software.
  • Experience in pharmaceutical and/or device research required.

Interested in this position?

Apply directly on the company website

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