Innovaderm Research Inc.

Project Manager

• Ensure successful initiation, planning, execution, monitoring, controlling and closure of assigned early-phase clinical research projects
• Manage and oversee clinical investigative sites and clinical monitoring deliverables
• Serve as a primary contact for sponsors, sites, CRAs, vendors and internal teams
• Coordinate tasks and deadlines across project departments
• Oversee site activation resources and coordinate vendor supplies and services
• Escalate risks to site activation timelines
• Manage stakeholder needs and expectations
• Plan project activities and resources
• Manage quality of assigned work and deliverables
• Provide project status updates
• Ensure tasks comply with budgets, scope, timelines, SOPs, GCP, regulatory and study-specific requirements
• Reconcile study trackers and analyze planned-versus-actual discrepancies
• Participate in corrective actions, change control and risk management
• Review and assist with project operational plans, processes and manuals
• Ensure study documents and deliverables meet country requirements
• Oversee site selection, feasibility questionnaires and site qualification visits
• Monitor patient recruitment and subject status
• Participate in Investigator Meetings
• Oversee central ethics and regulatory submissions with Regulatory Affairs
• Collect and maintain essential site documentation
• Assist with TMF quality reviews and audits
• Support clinical monitoring activities, CRA training, monitoring tools, visit report reviews and site issue identification
• Track site visits, training, monitoring reports, follow-up letters and site-related escalations
• Maintain the project training matrix
• Ensure sites have required investigational products, supplies, equipment and laboratory kits
• Support CRF compliance, query resolution and data review through database lock
• Develop study trackers and site/Sponsor dashboards in Smartsheet
• Provide technical, therapeutic and project management expertise for training and process improvement
• After documented training, perform limited clinical monitoring visits according to monitoring plans, SOPs, ICH/GCP guidelines and applicable regulations

Project Manager – Early Phase and Translational Research

Conversion Rate Optimizer

• Monitor the progress of clinical studies at investigative sites or remotely
• Ensure clinical trials are conducted, recorded, and reported according to the protocol, SOPs, ICH-GCP, and applicable regulatory requirements
• Conduct site qualification, initiation, monitoring, and close-out visits according to the monitoring plan and applicable guidelines
• Participate in investigators’ meetings
• Prepare site visit reports and follow-up letters to investigators
• Build productive relationships with investigators and site staff to achieve study objectives and patient recruitment targets
• Perform source data verification
• Ensure on-site study drug storage, dispensing, and accountability are adequate
• Ensure data collection and regulatory document collection are adequate
• Take on other responsibilities when appropriately experienced, qualified, and/or trained

Project Manager – Early Phase and Translational Research

Freelance CRA, Dermatology/Rheumatology