Innovaderm Research Inc.
Innovaderm Research Inc.
Innovaderm Research Inc. ir dermatoloģijā specializēta līgumisko klīnisko pētījumu organizācija (CRO), kas atbalsta klīnisko izstrādi no I līdz IV fāzei. Kopš 2000. gada uzņēmums sadarbojas ar farmācijas un veselības aprūpes organizācijām Ziemeļamerikā un Eiropā, nodrošinot dermatoloģijas pētījumu izstrādi, konsultācijas regulējuma jautājumos, projektu vadību, pacientu piesaisti un datu pārvaldību.

Remote Project Director, Dermatology and Rheumatology

Lead multinational dermatology and rheumatology clinical study portfolios at Indero, overseeing project managers, budgets, regulatory compliance, and client delivery.

Apraksts

  • Direct a portfolio of clinical studies and the project managers responsible for delivering them.
  • Ensure studies meet therapeutic-area and client requirements.
  • Represent the company to customers and sustain client satisfaction.
  • Communicate program deliverables clearly and effectively.
  • Keep studies aligned with quality standards, SOPs, GCP, ICH guidelines, and applicable regulations.
  • Oversee executed contracts and study finances, including budgets and expenses.
  • Track and assess project progress with timelines and analytical tracking tools.
  • Build and maintain detailed knowledge of the assigned portfolio’s therapeutic areas and clients.
  • Apply lessons from individual studies across assigned studies and client engagements.
  • Lead contingency planning and risk-reduction efforts.
  • Contribute operational expertise and strategy to proposal development and pricing.
  • Advance performance, operational efficiency, and innovative approaches.
  • Provide line-management oversight and support project management leadership as an operational and therapeutic-area expert.

Prasības

  • Bachelor of Science degree in a relevant field.
  • At least 15 years of industry experience.
  • At least 5 years of experience at a CRO.
  • At least 10 years managing clinical projects, covering every phase from start-up through closeout, functional services, and vendors.
  • Experience with mid-size and large studies spanning more than 10–15 countries across multiple regions (North America, South America, APAC, MENA, and Europe) is preferred.
  • Experience leading concurrent, multicenter, multinational Phase III trials, including project budget tracking and forecasting.
  • Extensive experience supervising, mentoring, and coaching project managers.
  • Substantial business development experience, such as preparing proposals, presenting to clients, and participating in bid-defense meetings.
  • Experience mentoring and coaching a representative number of project managers.
  • Dermatology or rheumatology experience is required.
  • Strong knowledge of Good Clinical Practice.
  • Knowledge of applicable Health Canada and U.S. Food and Drug Administration regulations and guidelines.
  • PMP or PRINCE2 certification is an asset.
  • A master’s degree is an asset.

Priekšrocības

  • Flexible work schedule.
  • Home-based position.
  • Ongoing learning and development.
  • 401(k) plan.
  • Benefits package.
  • Bonus plan.
  • Career advancement opportunities.

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