Innovaderm Research Inc.

Director

• 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.

Project Director

Project Manager

• 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

Project Director

Project Manager – Dermatology