Innovaderm Research Inc.

Project Director

Innovaderm Research Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Lead

Tech Stack

PMP

About the role

  • Oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets.
  • Oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects.
  • Leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise.
  • Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements.
  • Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively.
  • Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines.
  • Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses.
  • Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
  • Applies study specific learning across assigned portfolio of studies/clients.
  • Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery.
  • May lead operational input to proposal development and pricing including proposed operations strategy.
  • Drives performance improvement, operational efficiencies and innovative strategies.
  • May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert.

Requirements

  • You have at least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management.
  • Experience in dermatology or rheumatology trials is required
  • At least 15 years industry experience and a minimum of 5 years at a CRO
  • Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable.
  • Experience leading concurrent multi-centered, multinational phase III clinical trials including project budget financial tracking and forecasting
  • Substantial experience in project supervision, mentoring and coaching project managers
  • Substantial experience with business development tasks, such as development of proposals, client presentations, bid defense meetings, and the like
  • Participation in mentoring and coaching of a representative number of project managers
  • Bachelor of Science in a relevant discipline. A Master’s degree is an asset.
  • PMP or PRINCE2 Certification is an asset.
  • Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines
  • Indero only accepts applicants who can legally work in the United States.