Manager, Clinical Content & Quality Operations - InCircle

Overview

The Manager, Clinical Content & Quality Operations provides both strategic direction and operational leadership for InCircle’s clinical documentation, extraction, and adjudication functions. This position is accountable for the quality, accuracy, and regulatory integrity of all clinical content supporting client deliverables, ensuring that processes align with contractual obligations and industry standards. This role serves as the central point of coordination across multiple disciplines—clinical operations, data analytics, engineering, and quality assurance—to drive consistency, scalability, and performance in content development and adjudication workflows.

The Manager oversees a team responsible for clinical extraction, quality review, and process documentation, while leading initiatives to optimize workflow automation, reduce operational risk, and enhance client confidence. In this role, the Manager combines clinical insight with hands-on operational leadership to ensure precision, compliance, and quality in every deliverable, translating complex scientific and regulatory requirements into efficient, scalable processes that strengthen team performance, uphold audit readiness, and consistently exceed client expectations.

• Lead the planning, execution, and continuous improvement of extraction, clinical content, and adjudication preparation workflows.
• Develop and implement operational frameworks, quality metrics, and performance indicators to ensure accuracy, compliance, and efficiency.
• Provide day-to-day leadership, mentorship, and performance management for a multidisciplinary team of Extractors, Quality Specialists, and content reviewers.
• Build organizational readiness by aligning staffing models, resource planning, and process scalability to projected business growth.
• Partner with senior leadership to align departmental initiatives with enterprise-wide quality, compliance, and client engagement strategies.

• Oversee the end-to-end lifecycle of clinical content, ensuring all deliverables meet internal standards and client specifications for accuracy, clarity, and regulatory compliance.
• Serve as the subject matter expert (SME) for content governance, data validation, and SOP development.
• Implement robust quality assurance systems, including peer review processes, CAPA management, and ongoing performance audits.
• Ensure adherence to GCP, FDA, and ICH documentation standards across all content and adjudication activities.
• Lead and coordinate responses to client and internal audits, maintaining audit readiness at all times.

• Establish a culture of measurable excellence through the development and monitoring of KPIs related to turnaround time, error reduction, and operational throughput.
• Conduct root cause analyses and develop corrective/preventive action (CAPA) plans that directly improve process efficiency and reduce compliance risk.
• Collaborate with IT to design and refine automation tools that enhance extraction and quality control workflows.
• Standardize documentation practices and drive the adoption of data-driven decision-making across all operational functions.
• Identify opportunities to modernize systems, increase scalability, and improve cost efficiency without compromising quality.

• Partner with Project Management to synchronize timelines, deliverables, and client communication plans.
• Collaborate with Data Analytics and Engineering teams to optimize automation, reporting accuracy, and platform usability.
• Work closely with Quality and Compliance to align policies, SOPs, and documentation with regulatory expectations.
• Represent the department in cross-functional steering committees to ensure consistency in operational standards and performance goals.
• Provide business intelligence and feedback loops to leadership, informing strategic decisions and forecasting future capacity needs.

• Serve as the operational point of contact for assigned clients, ensuring clarity, transparency, and accountability in deliverables.
• Represent InCircle in client-facing meetings, audits, and performance reviews, articulating process capability and continuous improvement efforts.
• Support business development initiatives through operational input, documentation insights, and readiness planning for new client onboarding.
• Foster trusted partnerships by anticipating client needs, resolving issues proactively, and maintaining a high standard of service excellence.

• Develop and maintain comprehensive reporting frameworks that monitor operational performance, SLA compliance, and resource utilization.
• Translate operational data into actionable insights, highlighting trends, risk indicators, and opportunities for improvement.
• Present analytical reports to InCircle leadership, providing recommendations that align…