Risk

• Manage the Quality team to ensure delivery of departmental and organizational quality objectives.
• Define and implement the CPC Quality program and ensure that it is robust and adheres to all internal and external requirements as governed by the CPC scope of activities.
• This program should be proactive in evolving, innovating, and anticipating organizational risks and quality gaps.
• Define and oversee implementation of quality policies, procedures, and metrics.
• Provide the Executive Director and Leadership Committee with key updates on a regular basis.
• Ensure quality processes, tasks, and deliverables are on track and on schedule.
• Identify strategic gaps, risks or deficiencies and work with the Executive Director to address them.
• Champion CPC’s Quality Management System (QMS) and regulatory technologies.
• Oversee the review, revision, approval, version control, and historical archival of controlled documents within the QMS.
• Ensure compliance with regulatory requirements (e.g., FDA, HIPAA, GCP) and internal quality standards.
• Identify potential areas of non-compliance or inefficiency and develop proactive measures to address them.
• Lead internal auditing functions to ensure that CPC is compliant with all applicable local, federal and international regulations, guidelines and standards.
• Oversee external audits of CPC and responses to audit observations or requests, in conjunction with appropriate Leadership Committee members.
• Represent CPC in interactions with the FDA and other regulatory bodies.
• Maintain and manage all GxP Clinical Systems documentation from implementation, change management, user access and audit trail review, and retirement to ensure data integrity, security and regulatory compliance.
• Conduct external audits and risk assessments for all technology systems (on-prem, software as a service (SAAS), cloud-based, etc.), if applicable.
• Oversee and support the build and validation of electronic data capture (EDC) clinical trial databases.
• Lead the organizational development and maintenance of quality assurance policies, SOPs, and process documentation.
• Identify process gaps and revise policies (POLs), standard operating procedures (SOPs) and work instructions (WIs) to ensure compliance with applicable regulations and regulatory guidance.
• Prepare and present quality performance reports to senior leadership.
• Lead initiatives for continuous improvement in the Quality Department.
• Report on all significant or concerning regulatory and/or quality issues to the Executive Director.
• Serve as an internal subject matter expert to address and resolve regulatory or quality assurance issues.
• Supervise and lead quality team members to set clear job expectations, assess training needs and ensure team members receive training as needed.
• Assist all personnel reporting to this position to create improvement and innovation goals annually.
• Maintain a Society of Quality Assurance membership and participate in IT System workshops.
• Maintain certification in CITI training as appropriate for role.

Associate Director – Quality Programs and Governance

Business Development Rep

• Serve as the primary liaison for new study proposals, budget negotiations, and contract execution
• Lead proposal development for new studies and consulting engagements, collaborating with internal teams to craft compelling responses and accurate budgets.
• Create and update budgets for proposals
• Work with finance to optimize budget models and update them for changes in services
• Manage timelines for proposals, bid defenses, and contract negotiations to ensure timely delivery and alignment with client expectations.
• Maintain and update standardized templates for proposals and client-facing materials.
• Serve as the go-to resource for internal teams regarding scope of work, budget amendments, and task allocations.
• Maintain and evolve standardized templates and materials for proposals, capabilities presentations, and client communications.
• Partner with Legal Affairs to execute confidentiality agreements and ensure compliance during pre-contract phases.
• Coordinate vendor quotes and external meetings related to proposals, budgets, and strategic discussions.

Clinical Trials Business Development Manager

Engineering Manager

• Serve as lead engineer on core software initiatives, personally authoring critical components, frameworks, and integrations.
• Design and implement high-quality, secure, and scalable software systems to support clinical trial operations, workflow automation, and data management.
• Own technical architecture decisions, ensuring software is modular, maintainable, and aligned with CPC’s long-term roadmap.
• Establish coding standards, development practices, and peer review processes to ensure code quality and reliability.
• Balance speed of delivery with robust validation, testing, and compliance in a regulated environment.
• Translate strategic initiatives into concrete technical plans and lead day-to-day software delivery across internal and external teams.
• Drive adoption of agile engineering practices, DevOps pipelines, and continuous delivery; oversee technical design and code reviews.
• Architect and implement core software platforms including workflow automation tools, clinical data systems, integration layers, APIs, services, and data pipelines.
• Evaluate third-party components and lead build-vs-buy decisions with bias toward proprietary solutions.
• Recruit, mentor, and grow a high-performing software engineering team and provide technical coaching to junior engineers.
• Implement software systems for high-quality, audit-ready data collection and management and ensure compliance (21 CFR Part 11, HIPAA).
• Act as Managing Director of Technology’s right hand to move initiatives from concept to production with speed and rigor.
• Collaborate with data scientists and clinical teams to enable analytics, reporting, and AI-driven insights.

Associate Director, Software Engineering

Director

• Define and execute the company’s data integration technology current and multi-year vision, strategy, and roadmap in alignment with business goals.
• Act as a strategic advisor to the Executive Director and leadership team on all technology matters, including digital innovation, systems modernization, and data strategy.
• Champion a culture of innovation, agility, and continuous improvement across technology functions.
• Partner with senior leaders across the organization to understand needs and co-design streamlined processes and technology-enabled solutions.
• Lead a cross-functional program to reengineer critical operational processes (e.g., clinical trial management, data collection, regulatory submissions) through automation, digitization, and advanced analytics.
• Evaluate current systems, workflows, and pain points, and introduce modern solutions that improve speed, accuracy, and scalability.
• Leverage technology to enhance regulatory compliance, data integrity, standardization and audit readiness.
• Drive vendor selection, build-vs-buy decisions, and implementation of foundational technology and core platforms.
• Own delivery of key technology initiatives – from architecture to implementation – ensuring timelines, budgets, and quality expectations are met.
• Take an active, hands-on role in high-priority projects (e.g., workflow automation, data integration).
• Establish and lead agile delivery processes, resource planning, backlog prioritization, and vendor/partner management.
• Define clear KPIs and delivery metrics to track progress and communicate status to stakeholders.
• Build and lead a high-performance data and technology team, that delivers solutions that enable smarter, faster, and compliant clinical operations, while scaling internal capabilities as needed.
• Foster a culture of accountability, technical excellence, and collaborative problem-solving.
• Implement modern engineering practices (e.g., continuous integration/delivery/deployment, automated testing, secure coding standards) appropriate to a regulated environment.
• Lead the development of a modern data infrastructure and new software to support operational efficiency, advanced analytics, and machine learning use cases.
• Ensure effective data governance, integration, and accessibility across the organization.
• Collaborate with clinical and operational teams to develop digital tools that enhance decision-making and trial execution.
• Lead modernization of core platforms, including clinical systems, document and data management, and reporting tools.
• Build a foundational technological infrastructure to support scalable operations and growth.
• Develop streamlined, automated core processes with measurable improvements in speed, accuracy, and auditability
• Ensure all systems and processes are compliant with relevant regulations (e.g., 21 CFR Part 11), and support audit readiness.
• Perform additional activities as required.