The Manager of Research Regulatory Affairs oversees regulatory operations, ensures compliance with FDA and GCP guidelines, and manages the regulatory department. They are responsible for developing regulatory strategies, managing relationships with industry sponsors, and mentoring regulatory staff.
The Lead Data Architect will design, build, and manage the organization's data infrastructure while developing a comprehensive data strategy. They will collaborate with stakeholders to integrate AI models and ensure data integrity, security, and compliance across all systems.
The Reconciliation Analyst is responsible for reconciling clinical trial receivables and ensuring accurate billing to pharmaceutical companies. They will review financial study data, interpret contracts, and collaborate with various departments to resolve variances and ensure reporting deadlines are met.
The Clinical Project Associate is responsible for maintaining the Trial Master File in an audit-ready condition throughout the study lifecycle. They will also perform quality reviews of clinical documents and collaborate with cross-functional teams to ensure project deliverables are met.
The Senior Manager of Research Regulatory Affairs oversees regulatory operations, including trial start-up, maintenance, safety, and conflict of interest compliance. They lead cross-functional teams to streamline processes, manage relationships with industry partners and the FDA, and ensure adherence to clinical research standards.
The Medical Writer is responsible for researching, writing, and editing clinical documents such as protocols and study reports for regulatory submissions. They also serve as the primary point of contact for sponsors and ensure document quality through rigorous editing and version control.
The Director will lead strategic client engagement and relationship management, overseeing key pharma and strategic partner relationships. They are responsible for establishing governance frameworks, driving retention, and managing cross-functional teams to ensure consistent partner support.
The Budget Analyst will interpret clinical trial protocols to develop, negotiate, and present financial budgets to executive management. They are responsible for maintaining budget statuses and collaborating with clinical staff to ensure accurate financial planning.
The Senior Product Analyst will lead digital transformation initiatives by identifying process gaps and translating business needs into system requirements for clinical research solutions. They will collaborate with cross-functional teams to design, implement, and optimize product features while providing tier 2 support to end users.
The Vice President of Clinical Quality Assurance provides strategic leadership and operational oversight for the organization's Quality Management System to ensure regulatory compliance and research integrity. This role is responsible for driving a culture of quality, managing inspection readiness, and mentoring a high-performing team to support organizational growth.
The Application Engineer II provides technical support and administration for enterprise applications, including configuring, testing, and troubleshooting system solutions. They also manage integrations, triage user incidents, and collaborate with cross-functional teams to ensure operational efficiency and compliance.
The Accounts Receivable Analyst is responsible for collecting client receivables, resolving disputes, and maintaining study finance trackers. They will also collaborate with internal departments to reconcile financial data and ensure timely payments from sponsors and CROs.
The Senior Director provides enterprise-wide leadership for revenue cycle operations, overseeing the full research revenue cycle from budget development to revenue realization. They are responsible for driving operational excellence, financial performance, and process standardization across the SMO and CRO network.
The IT Quality Control Specialist oversees software, process, and data integrity validation to ensure compliance with GxP and regulatory requirements. They provide guidance to operational teams and review validation life cycle documentation including system plans and risk management reports.
