Innovaderm Research Inc.

Project Manager – Dermatology

Innovaderm Research Inc.

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

Tech Stack

Google Cloud Platform

About the role

  • Serve as primary contact for the Sponsor and lead client interactions
  • Provide efficient and timely updates on trial progress and lead client calls
  • Oversee preparation of project deliverables: study plans, protocol, informed consent form, eCRF, TLFs, clinical study report
  • Participate in planning and conduct of Investigator’s Meeting
  • Ensure sites have necessary materials (investigational product, supplies, equipment, lab kits)
  • Ensure studies are audit ready and monitor quality of study and vendor/SubCRO deliverables
  • Manage risk and control measures and review/approve QA audit responses
  • Control project budget, monitor internal hours, identify out-of-scope activities and change orders
  • Proactively manage timelines, resources, recruitment status, and vendors
  • Coordinate tasks and deliverables from all functional departments and communicate with senior management
  • Lead core project team (Associate PMs, Project Coordinators, Project Assistants) and ensure team training
  • Work closely with Site Selection, Regulatory Affairs, Data Management, Clinical Monitoring, Biostatistics, Scientific Affairs

Requirements

  • B.Sc. in a relevant discipline
  • At least 5 years of industry experience
  • Minimum 3 years leading multi-center clinical trials (Phase II-III)
  • Experience leading concurrent multi-centered clinical trials with budgets in excess of $3M USD
  • Experience managing dermatology trials
  • Experience managing rheumatology trials an asset
  • Excellent knowledge of GCP and ICH standards
  • Knowledge of FDA and local country regulations
  • Good knowledge of Health Canada and FDA regulations/guidelines
  • Excellent knowledge of Microsoft Office suite
  • Fluency in English with excellent oral and written skills
  • Ability to work in a team environment and establish good relationships with colleagues and sponsors
  • Good problem-solving abilities
  • Strong ability to manage multiple projects and work under pressure while meeting timelines
  • Must be legally authorized to work in the US