Principal

• Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate study milestones
• Promote awareness of the sponsor’s clinical pipeline and programs to trial sites, investigators, and networks
• Conduct Monitoring Oversight Visits to assess FSP CRA monitoring quality and site inspection readiness
• Execute remote or on-site site qualification and facilitate site selection
• Schedule and conduct Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs across oncology trials
• Review and approve FSP CRA Monitoring Visit Reports
• Review site and monitoring Key Risk Indicator metrics and contribute to the Study and Site Risk Assessment Tool
• Train and retrain FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents
• Perform site management and act as an escalation point for FSP CRA monitoring quality issues
• Develop or ensure implementation of site CAPA Plans and escalate issues as needed
• Ensure sites are inspection-ready and support the sponsor during site inspections
• Utilize CTMS and TMF to file documents, maintain accurate site data, and audit site TMFs as needed
• Draft, review, or contribute to Site Monitoring Plans
• Contribute to monitoring process improvement initiatives, SOPs, work instructions, job aids, and tools
• Improve site selection, monitoring, and monitoring oversight templates in Veeva CTMS and EDC
• Establish relationships with investigators, site staff, sponsor study team members, and FSP CRAs

Lead CRA / Principal CRA

• Serve as a technical subject matter expert supporting biologics and injectable applications across the sales cycle
• Provide technical support to biopharma customers and enable development and implementation of Roquette solutions at strategic and key accounts
• Build and maintain scientific relationships with customer R&D, formulation, and process teams
• Define solution strategies for customer development challenges and bottlenecks
• Guide customers in selection, evaluation, and implementation of Roquette’s portfolio
• Identify, evaluate, and help develop new commercial opportunities and strategic partnerships
• Liaise between customers and internal technical teams to ensure alignment and timely communication and delivery of solutions
• Capture and communicate customer feedback and unmet needs to inform product development and application strategy
• Design, execute, and publish studies evaluating new and existing products with cross-functional business unit teams
• Develop technical marketing materials, including white papers, case studies, technical presentations, and data packages
• Deliver technical presentations and training to internal audiences
• Represent Roquette at scientific conferences, trade shows, and industry forums
• Stay current with trends in biologics, drug development, manufacturing technologies, and regulatory requirements

Principal jobs in Pennsylvania

Lead CRA / Principal CRA

Principal Customer Solutions Scientist