FFF Enterprises · 7 hours ago
Manager, Clinical Content & Quality Operations - InCircle
Temecula, CA
Full-time
Onsite
Mid, Senior Level
$125K/yr - $155K/yr
5+ years expFFF Enterprises is focused on providing strategic direction and operational leadership for clinical documentation and quality operations. The Manager, Clinical Content & Quality Operations is responsible for ensuring the accuracy and regulatory integrity of clinical content while overseeing a multidisciplinary team and driving process optimization.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
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 operational performance with organizational strategy
Integrate metrics into team performance management to reinforce accountability and continuous improvement
Adheres specifically to all company policies and procedures, Federal and State regulations, and laws
Display dedication to position responsibilities and achieve assigned goals and objectives
Always represent the Company in a professional manner and appearance
Understand and internalize the Company’s purpose
Display loyalty to the Company and its organizational values
Display enthusiasm and dedication to learning how to be more effective on the job and share knowledge with others
Work effectively with co-workers, internal and external customers and others by sharing ideas in a constructive and positive manner; listen to and objectively consider ideas and suggestions from others; keep commitments; keep others informed of work progress, timetables, and issues; address problems and issues constructively to find mutually acceptable and practical business solutions; address others by name, title, or other respectful identifier, and respect the diversity of our work force in actions, words, and deeds
Comply with the policies and procedures stated in the Injury and Illness Prevention Program by always working in a safe manner and immediately reporting any injury, safety hazard, or program violation
Ensure conduct is consistent with all Compliance Program Policies and procedures when engaging in any activity on behalf of the company. Immediately report any concerns or violations
Other duties as assigned
Qualification
Required
Bachelor's degree in Life Sciences, Clinical Research, or a closely related discipline, demonstrating a foundational understanding of scientific principles, regulatory environments, and data integrity standards
In lieu of degree, a minimum of seven (7) years' experience may substitute for formal education
Comprehensive understanding of clinical research operations, including study design, data extraction, documentation standards, and quality management systems within a regulated environment
Strong working knowledge of GCP, FDA, and ICH E6(R2) guidelines, with proven ability to interpret and apply compliance frameworks governing documentation, audit readiness, and data integrity
Minimum of five (5) years of progressive experience in clinical trial operations, medical writing, or quality assurance within a regulated or GxP-compliant environment
Demonstrated success in leading or managing cross-functional teams responsible for clinical content creation, data analysis, or quality operations
Proven ability to deliver high-quality client-facing outputs under compressed timelines while maintaining strict adherence to compliance, accuracy, and documentation standards
Exceptional written and verbal communication skills, with the ability to synthesize complex scientific and operational concepts into clear, actionable insights for technical and executive audiences
Proven leadership and interpersonal influence, fostering collaboration, accountability, and engagement across diverse, cross-functional teams
Advanced analytical, critical-thinking, and organizational expertise, exercising sound judgment and precision under pressure while effectively managing multiple concurrent priorities in a highly regulated environment
Expertise in process design, quality systems, and operational optimization, including workflow mapping, documentation control, and performance reporting to inform continuous improvement and strategic decision-making
Preferred
Master's degree or higher in Clinical Research, Life Sciences, or a related scientific or regulatory field, reflecting advanced analytical capability and subject matter depth relevant to clinical operations leadership
Familiarity with AI-assisted data extraction platforms, workflow automation tools, and technology-driven process optimization within clinical or life sciences organizations
Advanced understanding of document control systems, eQMS applications, and audit preparedness best practices utilized by CROs, sponsors, or regulated healthcare entities
Demonstrated experience leveraging business intelligence platforms (e.g., Power BI, Tableau) for KPI monitoring, trend analysis, and operational forecasting
Proficiency with documentation and quality management platforms such as Veeva, MasterControl, or comparable eQMS solutions
Advanced technical writing and editorial proficiency with the ability to translate clinical or operational data into structured, compliant documentation for internal and external review
Project Management Professional (PMP)
Certified Clinical Research Professional (CCRP)
Certified Quality Auditor (CQA)
Company
FFF Enterprises
FFF Enterprises is a Pharmaceuticals supplier of critical-care biopharmaceuticals, plasma products and vaccines.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
$1.12B2025-02-05Debt Financing· $1.12B
Leadership Team
Shay Reid
Chief Operating Officer
Recent News
FFF Enterprises.com
2025-11-12
FFF Enterprises.com
2025-09-30
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