ProPharma

Clinical Research

• Lead statistical activities for clinical trials and data analyses
• Provide statistical expertise to cross functional teams, including clinical operations, data management, and regulatory affairs
• Ensure the quality and accuracy of statistical deliverables, including statistical reports, tables, listings, and graphs
• Participate in the development and review of clinical study protocols and case report forms (CRFs)
• Develop and maintain SAS programs for statistical analysis in accordance with standard operating procedures (SOPs)
• Keep up to date with regulatory guidelines and industry standards related to biostatistics

Senior Biostatistician Consultant

Technical Writer

• Create and edit technical documents related to pharma manufacturing
• Collaborate with cross-functional teams to ensure document accuracy
• Support compliance with regulatory standards
• Assist in training and onboarding of staff for documentation practices

Quality Manufacturing Technical Writer

QA Engineer

• Support shorter-term manufacturing and quality-related needs
• Manage deviations
• Create and review protocols
• Oversee change control
• Perform batch reviews
• Address manufacturing questions
• Conduct investigations
• Follow laboratory protocols
• Provide technical and quality oversight

Manufacturing QA Resource

Financial Planning and Analysis

• Responsible for assisting with monthly billing across various service lines.
• Add new clients, items, and pricing to billing system as requested via Client Services, Operations, or Business Development from executed SOWs.
• Update billing system with changes in pricing and budgets as directed by Client Services, Operations, or Business Development from signed SOWs on existing clients.
• Assist in maintaining complete and accurate invoicing records and provide support to supervisor.
• Process adjustment requests as approved by Operations and Client Services.
• Support other entities within ProPharma, as capacity allows.
• Assist with preparation of month-end / year-end financial statements and budgets as they pertain to the above responsibilities.
• Assist with year-end financial audits as needed.
• Provide assistance and billing detail support to the Collections organization as part of collection activities for assigned customers.
• Track purchase order balances and communicate with Business Development when action is needed.
• Other duties as assigned.
• Provide support to Project Coordination team. This entails setting up contracts and client data into the ERP system.

Finance Specialist

Project Manager

• Provide core project administration support, including scheduling meetings, preparing agendas, documenting minutes, and tracking action items
• Actively participate in project meetings, contributing updates and ensuring follow-ups are clearly captured
• Support Project Managers in delivering project activities, including discovery work, documentation drafting, change management, and communication planning
• Maintain and organize project documentation, including plans, status reports, and shared files
• Update trackers, logs, and reports under the guidance of Project Managers
• Monitor project timelines and proactively follow up with team members on assigned tasks
• Assist in preparing presentations, dashboards, and reports using PMO templates
• Coordinate communication across project teams and escalate issues when appropriate
• Ensure proper document management, including version control and up-to-date records
• Support PMO tools, templates, and processes, helping maintain consistency and quality
• Contribute to continuous improvement initiatives within the PMO

Project Coordinator

• Provides guidance for quality activities and drives positive change and process improvement
• Performs, develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements
• Host and/or Support CRS/FSP client audit and/or regulatory authority inspection activities
• Develop responses to CAPAs arising from client/inspections, as applicable to CQA
• Collaborate with multiple lines of business to prepare for/conduct audits/inspections
• Support CRS/FSP project leadership in setup and subscription of Client and/or project-specific Deviation, Quality Event, and CAPA eQMS reports for Client provision
• Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports to facilitate identification of emerging trends
• Escalate emerging trends to Management for improvement opportunities

Senior Biostatistician Consultant

Quality Manufacturing Technical Writer

Manufacturing QA Resource

Finance Specialist

Project Coordinator

Clinical Quality Assurance Lead