Manager, Clinical Content & Quality Operations - InCircle

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Position Summary
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 both 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. The position requires the ability to translate complex scientific and regulatory requirements into efficient, scalable processes that strengthen team performance, uphold audit readiness, and consistently exceed client expectations.

Essential Functions and Duties

Leadership & Strategic Oversight:

• 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.

Clinical Content & Quality Management:

• 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.

Operational Excellence & Process Optimization:

• 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.

Cross-Functional Collaboration:

• 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.

Client & Stakeholder Engagement:

• 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.

Data Reporting & Business Intelligence:

• 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.

General Responsibilities:

• 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.

Education, Knowledge, Skills, and Experience

Required Education:

• 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.

Preferred Education:

• 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.

Required Knowledge:

• 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.

Preferred Knowledge:

• 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.

Required Experience:

• 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.

Preferred Experience:

• 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.

Required Skills:

• 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 Skills:

• 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.

Required Professional Certification:

• None.

Preferred Professional Certification:

• Project Management Professional (PMP)
• Certified Clinical Research Professional (CCRP)
• Certified Quality Auditor (CQA)

Physical requirements
Vision, hearing, speech, movements requiring the use of wrists, hands and/or fingers. Must have the ability to view a computer screen for prolonged periods and the ability to sit for extended periods. Must have the ability to work the hours and days required to complete the essential functions of the position, as scheduled. The employee occasionally lifts to 20 lbs. and occasionally kneels and bends. Must have the ability to travel occasionally. Working condition include normal office setting.
Mental Demands
Learning, thinking, concentration and the ability to work under pressure, particularly during busy times. Must be able to pay close attention to detail and be able to work as a member of a team to ensure excellent customer service. Must have the ability to interact effectively with co-workers and customers, and exercise self-control and diplomacy in customer and employee relations’ situations. Must have the ability to exercise discretion as well as appropriate judgments when necessary. Must be proactive in finding solutions.
Direct Reports
Yes
EEO Statement
FFF Enterprises and Nufactor are an equal opportunity employer and prohibits discrimination and harassment based on the following characteristics: race, color, religion, national origin, physical or mental disability, gender, age (40 years and over) qualified veteran and any other characteristic protected by state or federal anti-discrimination law covering employment. These categories are defined according to Government Code section 12920. The Company prohibits unlawful discrimination based on the perception that anyone has any of those characteristics or is associated with a person who has or is perceived as having any of those characteristics.

To be considered for a position with FFF Enterprises, Inc, applicants must complete and sign the application.
Employee Benefits Available for FFF Enterprises Team Members

Employee benefits include:

• Medical Insurance
• Dental Insurance
• Vision Discount Program
• Vision Insurance Plan
• Health Savings Account (HSA)
• Flexible Spending Account (FSA)
• Dependent Care Flexible Spending Account
• Employee Assistance Program (EAP)
• Group Life and AD&D
• Voluntary Supplemental Life Insurance Plans
• Short Term Disability
• Long Term Disability Income Protection
• 401k Profit Sharing Retirement Plan - Discretionary Match
• Discretionary Bonus
• Supplemental Insurance Plans
• Prepaid Legal/Identity Theft Plan
• Paid Holidays/Vacation/Sick Days
• Seven (7) Paid Holidays, Two (2) Week Vacation, Five (5) Sick Days, and One (1) Float Day for CA, NC, and TX

All Other States Receive One Hundred Twenty (120) Hours of PTO

• Tuition Reimbursement Program
• Notary Services
• Employee Referral Bonus
• Vendor Discount Programs
• Corporate Individual Travel Program

(Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for eligible applicants/employees to perform essential functions. Hire may be subject to passing a medical examination, and to skill and agility tests.)